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FDA 510(k)

RESPIRATOR MONITOR

K-Number: K813198 · 1981-12-08

ApplicantFlorida Medical Equipment Repair, Inc.
Decision Date1981-12-08
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATOR MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Florida Medical Equipment Repair, Inc.. It received FDA 510(k) clearance on 1981-12-08 under 510(k) number K813198. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATOR MONITOR?

RESPIRATOR MONITOR is a medical device that received FDA 510(k) clearance on 1981-12-08. The listed applicant is Florida Medical Equipment Repair, Inc.. The 510(k) number is K813198.

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

RESPIRATOR MONITOR received FDA 510(k) clearance on 1981-12-08, under 510(k) number K813198.

Who is the listed applicant for RESPIRATOR MONITOR?

The FDA 510(k) record lists Florida Medical Equipment Repair, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRATOR MONITOR?

The FDA product code for RESPIRATOR MONITOR is CCL.

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 Florida Medical Equipment Repair, 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.

K820353MONITRON MODEL JL-7

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

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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