Question 1

Who is the manufacturer of SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR?

Accepted Answer

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR (K863042).

Question 2

What is the FDA product code for SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR?

Accepted Answer

DSK. It is classified under 21 CFR 870.1110 as a Class 2 device in the Cardiovascular panel.

Question 3

When was SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR cleared by the FDA?

Accepted Answer

Jan 14, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K863042
Device Name	SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	DSK · Cardiovascular
Decision Date	Jan 14, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1110
Device Class	Class 2

SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR

Device Facts

Regulatory Classification

Identification