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FDA 510(k)

MEDIPART FACE MASK HEADSTRAP MP-9100

K-Number: K853573 · 1985-10-29

ApplicantMedipart Jerry Alexander
Decision Date1985-10-29
Product CodeBTK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDIPART FACE MASK HEADSTRAP MP-9100 is the device name listed in this FDA 510(k) record. The listed applicant is Medipart Jerry Alexander. It received FDA 510(k) clearance on 1985-10-29 under 510(k) number K853573. 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 MEDIPART FACE MASK HEADSTRAP MP-9100?

MEDIPART FACE MASK HEADSTRAP MP-9100 is a medical device that received FDA 510(k) clearance on 1985-10-29. The listed applicant is Medipart Jerry Alexander. The 510(k) number is K853573.

When did MEDIPART FACE MASK HEADSTRAP MP-9100 receive FDA 510(k) clearance?

MEDIPART FACE MASK HEADSTRAP MP-9100 received FDA 510(k) clearance on 1985-10-29, under 510(k) number K853573.

Who is the listed applicant for MEDIPART FACE MASK HEADSTRAP MP-9100?

The FDA 510(k) record lists Medipart Jerry Alexander as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIPART FACE MASK HEADSTRAP MP-9100?

The FDA product code for MEDIPART FACE MASK HEADSTRAP MP-9100 is BTK.

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Other records listing Medipart Jerry Alexander 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.

K896885DISPOSABLE RESPIRTORY KIT (MP-200)K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MK896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDK896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDK894138MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD

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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.K831008HEAD STRAPMedovations, Inc.K810991HEADSTRAPRespironics, 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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