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FDA 510(k)

RESPIRATION MONITOR

K-Number: K760104 · 1976-09-21

ApplicantAir-Shields, Inc.
Decision Date1976-09-21
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1976-09-21 under 510(k) number K760104. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATION MONITOR?

RESPIRATION MONITOR is a medical device that received FDA 510(k) clearance on 1976-09-21. The listed applicant is Air-Shields, Inc.. The 510(k) number is K760104.

When did RESPIRATION MONITOR receive FDA 510(k) clearance?

RESPIRATION MONITOR received FDA 510(k) clearance on 1976-09-21, under 510(k) number K760104.

Who is the listed applicant for RESPIRATION MONITOR?

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

What is the FDA product code for RESPIRATION MONITOR?

The FDA product code for RESPIRATION MONITOR is FLS.

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Other records listing Air-Shields, Inc. 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.

K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMK972309JM-102 JAUNDICE METERK971256DUO-LITE PHOTOTHERAPY SYSTEMK960980ISOLETTE INFANT INCUBATORK924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEK940951RW RESUCITAIRE INFANT RADIANT WARMER

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Related Devices (Code: FLS)

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.

K011597SMARTMONITOR 2, MODEL 4000Respironics Georgia, Inc.K991087HANNAH WIRELESS VITAL SIGNS MONITORIlife Systems, Inc.K962865REMBRANDT SYSTEMAirsep Corp.K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSProtocol Systems, Inc.K894973RESPITRACE PLUSHogan & HartsonK832999RESPIRATION MONITORLitton Medical Electronics

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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