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FDA 510(k)

P1OP2B OR P1O92T

K-Number: K954674 · 1997-01-30

ApplicantKay Borch A/S
Decision Date1997-01-30
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

P1OP2B OR P1O92T is the device name listed in this FDA 510(k) record. The listed applicant is Kay Borch A/S. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K954674. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P1OP2B OR P1O92T?

P1OP2B OR P1O92T is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Kay Borch A/S. The 510(k) number is K954674.

When did P1OP2B OR P1O92T receive FDA 510(k) clearance?

P1OP2B OR P1O92T received FDA 510(k) clearance on 1997-01-30, under 510(k) number K954674.

Who is the listed applicant for P1OP2B OR P1O92T?

The FDA 510(k) record lists Kay Borch A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P1OP2B OR P1O92T?

The FDA product code for P1OP2B OR P1O92T is FYA.

Related Devices (Code: FYA)

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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