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FDA 510(k)

HEADSTRAP

K-Number: K810991 · 1981-04-29

ApplicantRespironics, Inc.
Decision Date1981-04-29
Product CodeBTK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEADSTRAP is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810991. The device is classified under product code BTK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEADSTRAP?

HEADSTRAP is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Respironics, Inc.. The 510(k) number is K810991.

When did HEADSTRAP receive FDA 510(k) clearance?

HEADSTRAP received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810991.

Who is the listed applicant for HEADSTRAP?

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

What is the FDA product code for HEADSTRAP?

The FDA product code for HEADSTRAP is BTK.

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Related Devices (Code: BTK)

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.

K944949GENERAL ANESTHESIA SYSTEMVital Signs, Inc.K914335STRAP, HEAD, GAS MASKVital Signs, Inc.K854537HEADSTRAPLife Design Systems, Inc.K853573MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry AlexanderK831008HEAD STRAPMedovations, Inc.

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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