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FDA 510(k)

PDB II

K-Number: K830289 · 1983-03-25

Decision Date1983-03-25
Product CodeINQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PDB II is the device name listed in this FDA 510(k) record. The listed applicant is J.A. Gerber Therapeutical, Ltd.. It received FDA 510(k) clearance on 1983-03-25 under 510(k) number K830289. The device is classified under product code INQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDB II?

PDB II is a medical device that received FDA 510(k) clearance on 1983-03-25. The listed applicant is J.A. Gerber Therapeutical, Ltd.. The 510(k) number is K830289.

When did PDB II receive FDA 510(k) clearance?

PDB II received FDA 510(k) clearance on 1983-03-25, under 510(k) number K830289.

Who is the listed applicant for PDB II?

The FDA 510(k) record lists J.A. Gerber Therapeutical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PDB II?

The FDA product code for PDB II is INQ.

Related Devices (Code: INQ)

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.

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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