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FDA 510(k)

PRIME CADI-120

K-Number: K914148 · 1992-10-05

Decision Date1992-10-05
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIME CADI-120 is the device name listed in this FDA 510(k) record. The listed applicant is Prime Medical Products, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K914148. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME CADI-120?

PRIME CADI-120 is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Prime Medical Products, Inc.. The 510(k) number is K914148.

When did PRIME CADI-120 receive FDA 510(k) clearance?

PRIME CADI-120 received FDA 510(k) clearance on 1992-10-05, under 510(k) number K914148.

Who is the listed applicant for PRIME CADI-120?

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

What is the FDA product code for PRIME CADI-120?

The FDA product code for PRIME CADI-120 is MEB.

Related Clinical Trials

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.

Other records listing Prime Medical 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.

Related Devices (Code: MEB)

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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