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FDA 510(k)

TAP

K-Number: K964516 · 1997-01-24

ApplicantNellcor Puritan Bennett, Inc.
Decision Date1997-01-24
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TAP is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964516. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAP?

TAP is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K964516.

When did TAP receive FDA 510(k) clearance?

TAP received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964516.

Who is the listed applicant for TAP?

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

What is the FDA product code for TAP?

The FDA product code for TAP is LRK.

Other records listing Nellcor Puritan Bennett, Inc. as applicant

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Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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