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FDA 510(k)

SQUINN VITATEK 500 SERIES PHYSIOL. MONI

K-Number: K810755 · 1981-04-03

ApplicantVitatek
Decision Date1981-04-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SQUINN VITATEK 500 SERIES PHYSIOL. MONI is the device name listed in this FDA 510(k) record. The listed applicant is Vitatek. It received FDA 510(k) clearance on 1981-04-03 under 510(k) number K810755. 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 SQUINN VITATEK 500 SERIES PHYSIOL. MONI?

SQUINN VITATEK 500 SERIES PHYSIOL. MONI is a medical device that received FDA 510(k) clearance on 1981-04-03. The listed applicant is Vitatek. The 510(k) number is K810755.

When did SQUINN VITATEK 500 SERIES PHYSIOL. MONI receive FDA 510(k) clearance?

SQUINN VITATEK 500 SERIES PHYSIOL. MONI received FDA 510(k) clearance on 1981-04-03, under 510(k) number K810755.

Who is the listed applicant for SQUINN VITATEK 500 SERIES PHYSIOL. MONI?

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

What is the FDA product code for SQUINN VITATEK 500 SERIES PHYSIOL. MONI?

The FDA product code for SQUINN VITATEK 500 SERIES PHYSIOL. MONI is DRT.

Related Clinical Trials

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.

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Other records listing Vitatek as applicant

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.

K823052THE 500 MONITOR SERIES

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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