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FDA 510(k)

HEAD STRAP

K-Number: K831008 · 1983-05-09

ApplicantMedovations, Inc.
Decision Date1983-05-09
Product CodeBTK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEAD STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831008. 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 HEAD STRAP?

HEAD STRAP is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Medovations, Inc.. The 510(k) number is K831008.

When did HEAD STRAP receive FDA 510(k) clearance?

HEAD STRAP received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831008.

Who is the listed applicant for HEAD STRAP?

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

What is the FDA product code for HEAD STRAP?

The FDA product code for HEAD STRAP is BTK.

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Other records listing Medovations, 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.

K002363MEDOVATIONS ESOPHAGEAL DILATORK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK874309URETHAL CATHETER

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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 AlexanderK810991HEADSTRAPRespironics, 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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