FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
K Number: K941793
·
Decision Jun 21, 1995
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
20
Review Days
436
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Basic Information
- Device Name
- OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
- K Number
- K941793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mountain Medical Equipment, Inc.
- Date Received
- April 11, 1994
- Decision Date
- June 21, 1995
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Mountain Medical Equipment, Inc.
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|---|---|---|---|
| K923650 | SCOTTY | Jan 15, 1993 | Substantially Equivalent |
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| K914916 | ALPINE V | Sep 23, 1992 | Substantially Equivalent |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | Jul 19, 1990 | Substantially Equivalent |
| K893531 | CUFF SPECULUM | Jun 22, 1989 | Substantially Equivalent |
| K884084 | PORTABLE OXYGEN GENERATOR | Nov 21, 1988 | Substantially Equivalent |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | Jul 8, 1988 | Substantially Equivalent |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Oct 20, 1987 | Substantially Equivalent |
| K873170 | ARIES | Sep 25, 1987 | Substantially Equivalent |
| K864005 | ALPINE | Jan 28, 1987 | Substantially Equivalent |