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FDA 510(k)

SYSTEM 22 PAEDIATRIC MASK

K-Number: K940888 · 1994-04-19

ApplicantMedic-Aid , Ltd.
Decision Date1994-04-19
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM 22 PAEDIATRIC MASK is the device name listed in this FDA 510(k) record. The listed applicant is Medic-Aid , Ltd.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K940888. 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 SYSTEM 22 PAEDIATRIC MASK?

SYSTEM 22 PAEDIATRIC MASK is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Medic-Aid , Ltd.. The 510(k) number is K940888.

When did SYSTEM 22 PAEDIATRIC MASK receive FDA 510(k) clearance?

SYSTEM 22 PAEDIATRIC MASK received FDA 510(k) clearance on 1994-04-19, under 510(k) number K940888.

Who is the listed applicant for SYSTEM 22 PAEDIATRIC MASK?

The FDA 510(k) record lists Medic-Aid , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 22 PAEDIATRIC MASK?

The FDA product code for SYSTEM 22 PAEDIATRIC 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 Medic-Aid , Ltd. 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.

K991685HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSORK981772HALOLITE AAD SYSTEMK971933PORT-NEBK934749FREEWAY LITE NEBULIZER COMPRESSORK940887SYSTEM 22 ADULT MASKK933535VENTSTREAM DRUG NEBULIZER

View all 9 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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