FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K Number: K870911
·
Decision May 29, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
59
Review Days
84
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Basic Information
- Device Name
- INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
- K Number
- K870911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Bentley
- Date Received
- March 6, 1987
- Decision Date
- May 29, 1987
- Product Code
- CCC
- 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 |
|---|---|---|---|
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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Other Clearances by American Bentley
| K Number | Device Name | ||
|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | Feb 12, 1988 | Substantially Equivalent |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Nov 6, 1987 | Substantially Equivalent |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | Sep 1, 1987 | Substantially Equivalent |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | Sep 1, 1987 | Substantially Equivalent |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | Aug 24, 1987 | Substantially Equivalent |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | Mar 9, 1987 | Substantially Equivalent |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | Oct 20, 1986 | Substantially Equivalent |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | Sep 29, 1986 | Substantially Equivalent |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | Jul 15, 1986 | Substantially Equivalent |
| K860673 | OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B | Jun 26, 1986 | Substantially Equivalent |