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FDA 510(k)

PENASE

K-Number: K812877 · 1981-10-26

ApplicantAnalytab Products, Inc.
Decision Date1981-10-26
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PENASE is the device name listed in this FDA 510(k) record. The listed applicant is Analytab Products, Inc.. It received FDA 510(k) clearance on 1981-10-26 under 510(k) number K812877. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENASE?

PENASE is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Analytab Products, Inc.. The 510(k) number is K812877.

When did PENASE receive FDA 510(k) clearance?

PENASE received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812877.

Who is the listed applicant for PENASE?

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

What is the FDA product code for PENASE?

The FDA product code for PENASE is JTO.

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Other records listing Analytab Products, 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.

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Related Devices (Code: JTO)

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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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