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FDA 510(k)

PART NO. 66-00311

K-Number: K770927 · 1977-05-26

ApplicantHarlake Cyprane
Decision Date1977-05-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PART NO. 66-00311 is the device name listed in this FDA 510(k) record. The listed applicant is Harlake Cyprane. It received FDA 510(k) clearance on 1977-05-26 under 510(k) number K770927. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PART NO. 66-00311?

PART NO. 66-00311 is a medical device that received FDA 510(k) clearance on 1977-05-26. The listed applicant is Harlake Cyprane. The 510(k) number is K770927.

When did PART NO. 66-00311 receive FDA 510(k) clearance?

PART NO. 66-00311 received FDA 510(k) clearance on 1977-05-26, under 510(k) number K770927.

Who is the listed applicant for PART NO. 66-00311?

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

What is the FDA product code for PART NO. 66-00311?

The FDA product code for PART NO. 66-00311 is BZG.

Other records listing Harlake Cyprane 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.

K770928PART NO. 66-00121

Related Devices (Code: BZG)

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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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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