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FDA 510(k)

POCKET SPIROMETER

K-Number: K830995 · 1983-04-28

ApplicantP.K. Morgan Instruments, Inc.
Decision Date1983-04-28
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POCKET SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is P.K. Morgan Instruments, Inc.. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K830995. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKET SPIROMETER?

POCKET SPIROMETER is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is P.K. Morgan Instruments, Inc.. The 510(k) number is K830995.

When did POCKET SPIROMETER receive FDA 510(k) clearance?

POCKET SPIROMETER received FDA 510(k) clearance on 1983-04-28, under 510(k) number K830995.

Who is the listed applicant for POCKET SPIROMETER?

The FDA 510(k) record lists P.K. Morgan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POCKET SPIROMETER?

The FDA product code for POCKET SPIROMETER is BZK.

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Other records listing P.K. Morgan Instruments, 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.

K823463RIGHT TIME RHYTHM CLOCK

Related Devices (Code: BZK)

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

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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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