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FDA 510(k)

STOCK #64091-PEDIATRIC OXYGEN MASK

K-Number: K823532 · 1983-01-05

ApplicantB & F Medical Products, Inc.
Decision Date1983-01-05
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STOCK #64091-PEDIATRIC OXYGEN 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 1983-01-05 under 510(k) number K823532. 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 STOCK #64091-PEDIATRIC OXYGEN MASK?

STOCK #64091-PEDIATRIC OXYGEN MASK is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is B & F Medical Products, Inc.. The 510(k) number is K823532.

When did STOCK #64091-PEDIATRIC OXYGEN MASK receive FDA 510(k) clearance?

STOCK #64091-PEDIATRIC OXYGEN MASK received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823532.

Who is the listed applicant for STOCK #64091-PEDIATRIC OXYGEN 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 STOCK #64091-PEDIATRIC OXYGEN MASK?

The FDA product code for STOCK #64091-PEDIATRIC OXYGEN MASK is BYG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 OXYGENK913501TRACHEOSTOMY MASKK861325MAXI-USE O2 DEVICEK861054DISPOSABLE RESCUE BREATHING DEVICEK853004PORTABLE 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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