Atlas FDA

SIGMA MP MULTIPLACE HYPERBARIC CHAMBER

FDA 510(k) clearance K930748 · decided 1993-08-20

Clearance details

K-number
K930748
Device name
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
Applicant
Perry Baromedical Services
Decision
Substantially Equivalent
Date received
1993-02-12
Decision date
1993-08-20
Days to decision
189 days
Clearance type
Traditional
Product code
CBF
Device class
2
Regulation number
868.5470
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Riviera Beach, FL, US
Third-party review
No
Expedited review
No

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SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K140559)Sechrist Industries, Inc.2014-05-30
RSI 4200 (K102831)Reimers Systems, Inc.2011-08-19
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (K092991)Environmental Tectonics Corp.2010-08-13
FLEXI-LITE (K101262)Pressure-Tech, Inc.2010-06-10
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K100268)Sechrist Industries, Inc.2010-04-26
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (K082455)Gulf Coast Hyperbarics, Inc.2009-05-22
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS (K081506)Hyperbaric America, LLC2008-07-25

Recalls involving this device

No recalls on record reference this clearance.