FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR
K Number: K843422
·
Decision Oct 23, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
7
Applicant Total
120
Review Days
53
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Basic Information
- Device Name
- OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR
- K Number
- K843422
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5310
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ohmeda Medical
- Date Received
- August 31, 1984
- Decision Date
- October 23, 1984
- Product Code
- BSF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSF | Absorber, Carbon-Dioxide | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSF), ordered by most recent decision date.
KAB SYSTEM
FDA 510(k)
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OHMEDA GMS ABOSORBER
FDA 510(k)
FDA Class 1
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NITROUS OXIDE RECYCLER
FDA 510(k)
FDA Class 1
·Anesthesiology
OHIO GMS ABSORBER
FDA 510(k)
FDA Class 1
·Anesthesiology
OHIO ABSORBER
FDA 510(k)
FDA Class 1
·Anesthesiology
PENLON JUMBO CARBON DIOXIDE ABSORBER
FDA 510(k)
FDA Class 1
·Anesthesiology
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| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Apr 16, 2009 | Substantially Equivalent |
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| K070377 | GIRAFFE AND PANDA WARMER | Jul 11, 2007 | Substantially Equivalent |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Apr 16, 2004 | Substantially Equivalent |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |