BXY · Flowmeter, Calibration, Gas
Anesthesiology · 21 CFR 868.2350 · Class 1
Overview
| Product Code | BXY |
|---|---|
| Device Name | Flowmeter, Calibration, Gas |
| Regulation | 21 CFR 868.2350 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | Westmed Intl. | Sep 15, 1995 | SESE |
| K902917 | PRECISION MEDICAL ELIMINATOR | Precision Medical, Inc. | Jul 23, 1990 | SESE |
| K902916 | PRECISION MEDICAL NEB BLOCK | Precision Medical, Inc. | Jul 23, 1990 | SESE |
| K863510 | OXY-OFF(TM) | B&B Medical Technologies, Inc. | Oct 22, 1986 | SESE |
| K860516 | LSP MINILATOR | Life Support Products, Inc. | Feb 21, 1986 | SESE |
| K851460 | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA | Telectronics, Inc. | May 10, 1985 | SESE |
| K781523 | PFT GASES | Gardner Cryogenics | Dec 1, 1978 | SESE |
Top Applicants
- Precision Medical, Inc. — 2 clearances
- Westmed Intl. — 1 clearance
- Telectronics, Inc. — 1 clearance
- Life Support Products, Inc. — 1 clearance
- Gardner Cryogenics — 1 clearance
