Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OXYGEN MASKS 81420, 81421, 81471 & 81461

K-Number: K913383 · 1991-10-18

ApplicantSpecialty Packaging Producs, Inc.
Decision Date1991-10-18
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASKS 81420, 81421, 81471 & 81461 is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Packaging Producs, Inc.. It received FDA 510(k) clearance on 1991-10-18 under 510(k) number K913383. 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 OXYGEN MASKS 81420, 81421, 81471 & 81461?

OXYGEN MASKS 81420, 81421, 81471 & 81461 is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Specialty Packaging Producs, Inc.. The 510(k) number is K913383.

When did OXYGEN MASKS 81420, 81421, 81471 & 81461 receive FDA 510(k) clearance?

OXYGEN MASKS 81420, 81421, 81471 & 81461 received FDA 510(k) clearance on 1991-10-18, under 510(k) number K913383.

Who is the listed applicant for OXYGEN MASKS 81420, 81421, 81471 & 81461?

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

What is the FDA product code for OXYGEN MASKS 81420, 81421, 81471 & 81461?

The FDA product code for OXYGEN MASKS 81420, 81421, 81471 & 81461 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 Specialty Packaging Producs, 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.

K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERK913163NON REBREATHING VALVEK913422OXYGEN TUBING, 81503K913216TRACH T ADAPTERK913164NON REBREATHING MASKK913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589

View all 11 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.

↑