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FDA 510(k)

SYSTEM V.HEART RATE/RESPIR. RATE MONIT.

K-Number: K820114 · 1982-02-12

ApplicantNarco Air-Shields
Decision Date1982-02-12
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM V.HEART RATE/RESPIR. RATE MONIT. is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820114. 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 SYSTEM V.HEART RATE/RESPIR. RATE MONIT.?

SYSTEM V.HEART RATE/RESPIR. RATE MONIT. is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Narco Air-Shields. The 510(k) number is K820114.

When did SYSTEM V.HEART RATE/RESPIR. RATE MONIT. receive FDA 510(k) clearance?

SYSTEM V.HEART RATE/RESPIR. RATE MONIT. received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820114.

Who is the listed applicant for SYSTEM V.HEART RATE/RESPIR. RATE MONIT.?

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

What is the FDA product code for SYSTEM V.HEART RATE/RESPIR. RATE MONIT.?

The FDA product code for SYSTEM V.HEART RATE/RESPIR. RATE MONIT. is DRT.

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Other records listing Narco Air-Shields 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.

K810953MODEL 533 PHOTOTHERAPY UNITK810474PROBE COVERK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK802126ISOLETTE INCUBATOR C-100K792592AMBU UNIVERSAL SUCTION PUMPK792499AMBU PAEDI ANAESTHESIA SYSTEM

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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

View on FDA Database →

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

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