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Perry Baromedical Corporation: FDA-registered device maker in Riviera Beach, FL, United States, 10 510(k) clearances

Name: Perry Baromedical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Perry Baromedical Corporation is registered with the FDA (registration 1036464) in Riviera Beach, FL, United States. It lists 1 device type. The FDA files 10 510(k) clearances under its listings, the newest dated August 13, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1036464
Address: 3750 Prospect Ave, Riviera Beach, FL, United States, 33404
Owner or operator: Perry Baromedical Corporation (1036464)
Roles: Manufacturer
First device listed: November 13, 2007
Registered through: 2026
Brand names listed: Bara-Med, EMR (Electronic Medical Records) Integration Kit, Ground Monitoring System GMS Accessory, OSCAR, Sigma 1, Sigma 34, Sigma 36, Sigma 40 and more

Devices it lists

Device	Product code	Class	Role	Source
Chamber, Hyperbaric	CBF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 13, 2010	K092991	O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)	CBF	Substantially Equivalent	Environmental Tectonics Corp.	accessdata.fda.gov
June 11, 2008	K072427	SIGMA SERIES HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Perry Baromedical Corp.	accessdata.fda.gov
June 26, 2002	K020974	BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER	CBF	Unknown	Environmental Tectonics Corp.	accessdata.fda.gov
May 30, 2000	K993010	BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Environmental Tectonics Corp.	accessdata.fda.gov
November 12, 1999	K990927	SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Perry Baromedical Corp.	accessdata.fda.gov
February 24, 1999	K983648	SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM	CBF	Substantially Equivalent	Perry Baromedical Services	accessdata.fda.gov
July 2, 1998	K974868	SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Perry Baromedical Corp.	accessdata.fda.gov
August 20, 1993	K930748	SIGMA MP MULTIPLACE HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Perry Baromedical Services	accessdata.fda.gov
November 12, 1986	K862198	SIGMA II - DUAL PLACE HYPERBARIC CHAMBER	CBF	Substantially Equivalent	Perry Baromedical Services	accessdata.fda.gov
August 12, 1983	K832127	NAUTILUS MONOPLACE HYPERBARIC UNIT	CBF	Substantially Equivalent	Nautilus Environmedical Systems, Inc.	accessdata.fda.gov

Compare with other makers

All makers of Chamber, Hyperbaric

Updated August 13, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.