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FDA 510(k)

TRACHEOSTOMY MASK

K-Number: K913501 · 1992-01-13

ApplicantB & F Medical Products, Inc.
Decision Date1992-01-13
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY MASK is the device name listed in this FDA 510(k) record. The listed applicant is B & F Medical Products, Inc.. It received FDA 510(k) clearance on 1992-01-13 under 510(k) number K913501. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOSTOMY MASK?

TRACHEOSTOMY MASK is a medical device that received FDA 510(k) clearance on 1992-01-13. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K913501.

When did TRACHEOSTOMY MASK receive FDA 510(k) clearance?

TRACHEOSTOMY MASK received FDA 510(k) clearance on 1992-01-13, under 510(k) number K913501.

Who is the listed applicant for TRACHEOSTOMY MASK?

The FDA 510(k) record lists B & F Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHEOSTOMY MASK?

The FDA product code for TRACHEOSTOMY MASK is BYG.

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Other records listing B & F Medical Products, 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.

K942645B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REGK920573CANNULA NASAL OXYGENK861325MAXI-USE O2 DEVICEK861054DISPOSABLE RESCUE BREATHING DEVICEK853004PORTABLE OXYGEN UNITK843691PORTABLE OXYGEN UNIT

View all 18 devices →

Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

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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