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FDA 510(k)

PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE

K-Number: K962903 · 1998-03-03

ApplicantPrestige Medical Corp.
Decision Date1998-03-03
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Medical Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K962903. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE?

PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Prestige Medical Corp.. The 510(k) number is K962903.

When did PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE receive FDA 510(k) clearance?

PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE received FDA 510(k) clearance on 1998-03-03, under 510(k) number K962903.

Who is the listed applicant for PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE?

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

What is the FDA product code for PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE?

The FDA product code for PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE is FLE.

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Related Devices (Code: FLE)

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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