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FDA 510(k)

MEDI-DYNE APNEA MONITOR

K-Number: K760635 · 1976-09-21

ApplicantMed Dyne Inst., Inc.
Decision Date1976-09-21
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDI-DYNE APNEA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Med Dyne Inst., Inc.. It received FDA 510(k) clearance on 1976-09-21 under 510(k) number K760635. 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 MEDI-DYNE APNEA MONITOR?

MEDI-DYNE APNEA MONITOR is a medical device that received FDA 510(k) clearance on 1976-09-21. The listed applicant is Med Dyne Inst., Inc.. The 510(k) number is K760635.

When did MEDI-DYNE APNEA MONITOR receive FDA 510(k) clearance?

MEDI-DYNE APNEA MONITOR received FDA 510(k) clearance on 1976-09-21, under 510(k) number K760635.

Who is the listed applicant for MEDI-DYNE APNEA MONITOR?

The FDA 510(k) record lists Med Dyne Inst., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-DYNE APNEA MONITOR?

The FDA product code for MEDI-DYNE APNEA MONITOR is FLS.

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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

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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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