FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K Number: K924709
·
Decision Jan 17, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
33
Review Days
1216
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Basic Information
- Device Name
- SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
- K Number
- K924709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Air-Shields, Inc.
- Date Received
- September 18, 1992
- Decision Date
- January 17, 1996
- Product Code
- KLK
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | May 3, 1995 | Substantially Equivalent |
| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent |
| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | Mar 13, 1992 | Substantially Equivalent |