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FDA 510(k)

MONITOR, AERATION, TEC-TEST

K-Number: K770953 · 1977-07-14

ApplicantCastle Co.
Decision Date1977-07-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONITOR, AERATION, TEC-TEST is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K770953. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, AERATION, TEC-TEST?

MONITOR, AERATION, TEC-TEST is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Castle Co.. The 510(k) number is K770953.

When did MONITOR, AERATION, TEC-TEST receive FDA 510(k) clearance?

MONITOR, AERATION, TEC-TEST received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770953.

Who is the listed applicant for MONITOR, AERATION, TEC-TEST?

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

What is the FDA product code for MONITOR, AERATION, TEC-TEST?

The FDA product code for MONITOR, AERATION, TEC-TEST is FRC.

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Other records listing Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK833074CASTLE TEC-TEST S.M.A.R.T. PACKK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AER

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Related Devices (Code: FRC)

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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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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