FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AS 30/TCP MODULE
K Number: K831460
·
Decision Jul 12, 1983
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
30
Review Days
67
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Basic Information
- Device Name
- AS 30/TCP MODULE
- K Number
- K831460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Narco Scientific
- Date Received
- May 6, 1983
- Decision Date
- July 12, 1983
- 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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Other Clearances by Narco Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K830338 | NARCOTRACE 80 | Dec 22, 1983 | Substantially Equivalent |
| K831428 | AS 1740 INTERFACE MODULE | Oct 14, 1983 | Substantially Equivalent |
| K831429 | AS 191 ECG TELEMETRY MODULE | Oct 14, 1983 | Substantially Equivalent |
| K822835 | PZ-800 VOLUME VENTILATOR | Sep 29, 1983 | Substantially Equivalent |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Sep 12, 1983 | Substantially Equivalent |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Jun 8, 1983 | Substantially Equivalent |
| K831028 | TI-1000 TRANSPORT INCUBATOR | May 9, 1983 | Substantially Equivalent |
| K823899 | INFANT CARE SYSTEM | Apr 14, 1983 | Substantially Equivalent |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Apr 8, 1983 | Substantially Equivalent |
| K830654 | INFUSION PUMP RETROGRADE EXTEN. AS 715 | Mar 24, 1983 | Substantially Equivalent |