HMS-4000 Multichannel Physio Monit Syst, Modified

FDA 510(k) K910950 · Vitalog Monitoring,Inc.

Substantially Equivalent

510(k) numberK910950

Submission

Device name
HMS-4000 Multichannel Physio Monit Syst, Modified
Applicant
Vitalog Monitoring,Inc.
Redwood, CA, US
Received
February 26, 1991
Decision date
August 2, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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More from Vitalograph Ireland, Ltd.

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K935510VX4 Recording Pulse OximeterDQA · Traditional 07/01/1994SE
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Questions and answers

When was HMS-4000 Multichannel Physio Monit Syst, Modified cleared by the FDA?

HMS-4000 Multichannel Physio Monit Syst, Modified (K910950) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 157 days after the submission was received.

What is the product code of K910950?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.