FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITIKON TRANSCUTANEOUS GAS MONITORS
K Number: K813347
·
Decision Jan 26, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
51
Review Days
60
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Basic Information
- Device Name
- CRITIKON TRANSCUTANEOUS GAS MONITORS
- K Number
- K813347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Critikon Company, LLC
- Date Received
- November 27, 1981
- Decision Date
- January 26, 1982
- 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 Critikon Company, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | Sep 21, 2000 | Substantially Equivalent |
| K000500 | DINAMAP ADVANCED NIBP MODULE | May 26, 2000 | Substantially Equivalent |
| K992638 | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 | Feb 24, 2000 | Substantially Equivalent |
| K982342 | DINAMAP MPS SELECT PORTABLE MONITOR | Aug 14, 1998 | Substantially Equivalent |
| K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR | Jun 16, 1995 | Substantially Equivalent |
| K942700 | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 | Mar 1, 1995 | Substantially Equivalent |
| K933404 | CRITIKON CENTRAL STATIN MONITOR | Feb 9, 1994 | Substantially Equivalent |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | Dec 14, 1993 | Substantially Equivalent |
| K915697 | CRITIKON VITAL SIGNS MODULE | Jul 1, 1993 | Substantially Equivalent |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | May 17, 1993 | Substantially Equivalent |