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510(k) Data Aggregation

K Number

K191896

Device Name

Belimed Steam Sterilizer MST-H TOP 5000

Manufacturer

Belimed AG

Date Cleared

2019-10-31

(108 days)

Product Code

FLE

Regulation Number

880.6880

Intended Use

The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

Device Description

The Belimed Steam Sterilizers MST-H TOP 5000, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are available in a carriage loader and a ground loader (GR) version. The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and BowieDick Test cycles. The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):

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K Number

K170228

Device Name

Belimed Steam Sterilizer MST-H TOP 5000

Manufacturer

Belimed AG

Date Cleared

2017-05-12

(107 days)

Product Code

FLE

Regulation Number

880.6880

Intended Use

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

Device Description

The Belimed Steam Sterilizers MST-H, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are available in a carriage loader and a ground loader (GR) version. The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles. The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):

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