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FDA 510(k)

MOBILE MEDICAL MONITOR (M3(A))

K-Number: K963576 · 1997-02-28

ApplicantScientific Applications
Decision Date1997-02-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBILE MEDICAL MONITOR (M3(A)) is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Applications. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K963576. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILE MEDICAL MONITOR (M3(A))?

MOBILE MEDICAL MONITOR (M3(A)) is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Scientific Applications. The 510(k) number is K963576.

When did MOBILE MEDICAL MONITOR (M3(A)) receive FDA 510(k) clearance?

MOBILE MEDICAL MONITOR (M3(A)) received FDA 510(k) clearance on 1997-02-28, under 510(k) number K963576.

Who is the listed applicant for MOBILE MEDICAL MONITOR (M3(A))?

The FDA 510(k) record lists Scientific Applications as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBILE MEDICAL MONITOR (M3(A))?

The FDA product code for MOBILE MEDICAL MONITOR (M3(A)) is DRT.

Related Clinical Trials

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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