CBF · Class II · 21 CFR 868.5470

FDA Product Code CBF: Chamber, Hyperbaric

Leading manufacturers include Sechrist Industries, Inc., Perry Baromedical Corp. and Reimers Systems, Inc..

69
Total
69
Cleared
207d
Avg days
1979
Since
69 devices
25–48 of 69
Cleared Jun 19, 2002
OXYGEN TREATMENT HOOD
K011592
Amron International Diving Supply, Inc.
Anesthesiology · 391d
Cleared Jun 06, 2002
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866
Hyperbaric Technologies, Inc.
Anesthesiology · 357d
Cleared Nov 29, 2001
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121
Engineered Medical Technology, Inc.
Anesthesiology · 601d
Cleared Aug 16, 2001
INFANT OXYGEN TREATMENT HOOD
K011565
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 87d
Cleared Jul 18, 2001
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312
Khrunichev State Research & Production Space Centr
Anesthesiology · 79d
Cleared May 16, 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659
Sea-Long Medical Systems, Inc.
Anesthesiology · 71d
Cleared Dec 06, 2000
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795
Hypertec, Inc.
Anesthesiology · 90d
Cleared Aug 02, 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409
Hyperbaric Technologies, Inc.
Anesthesiology · 90d
Cleared May 30, 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010
Environmental Tectonics Corp.
Anesthesiology · 266d
Cleared Nov 12, 1999
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K990927
Perry Baromedical Corp.
Anesthesiology · 238d
Cleared Oct 22, 1999
HTU3
K984313
Hyox Systems , Ltd.
Anesthesiology · 324d
Cleared Jul 06, 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938
Tampa Hyperbaric Ent.
Anesthesiology · 399d
Cleared Feb 24, 1999
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648
Perry Baromedical Services
Anesthesiology · 131d
Cleared Jul 22, 1998
SANDS SERIES III HYPERBARIC CHAMBER
K972908
Sands Hyperbarics
Anesthesiology · 350d
Cleared Jul 02, 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868
Perry Baromedical Corp.
Anesthesiology · 185d
Cleared May 28, 1997
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
K952545
Wright Industries
Anesthesiology · 726d
Cleared Dec 05, 1996
HYPERBARIC CHAMBER
K960389
Tampa Hyperbaric Ent.
Anesthesiology · 318d
Cleared Oct 23, 1996
GSP1 - GAS SELECTION PANEL
K962869
Reimers Systems, Inc.
Anesthesiology · 92d
Cleared Oct 23, 1996
ODS1 - HOOD DRIVER
K962871
Reimers Systems, Inc.
Anesthesiology · 92d
Cleared Jul 01, 1996
LOUISVILLE LABS OXYGEN HEAD TENT
K955535
Louisville Laboratories, Inc.
Anesthesiology · 209d
Cleared Jan 25, 1996
SYSTEM ONE HYPERBARIC CHAMBER
K951044
Nth Systems, Inc.
Anesthesiology · 324d
Cleared Jun 13, 1995
MODEL 2500E/2500ER HYPERBARIC CHAMBER
K934164
Sechrist Industries, Inc.
Anesthesiology · 655d
Cleared Jun 13, 1995
MODEL 3200P/3200PR HYPERBARIC CHAMBER
K950386
Sechrist Industries, Inc.
Anesthesiology · 132d