FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
HYPERLITE
K Number: K905168
·
Decision Jul 22, 1991
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
68
Applicant Total
1
Review Days
248
Basic Information
- Device Name
- HYPERLITE
- K Number
- K905168
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- S.O.S. LTD.
- Date Received
- November 16, 1990
- Decision Date
- July 22, 1991
- Product Code
- CBF
- 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 |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBF), ordered by most recent decision date.
FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
Revitalair 430+
FDA 510(k)
FDA Class 2
·Anesthesiology
Revitalair 430F
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
FDA 510(k)
FDA Class 2
·Anesthesiology
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
FDA 510(k)
FDA Class 2
·Anesthesiology
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology