FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXIMETER
K Number: K871353
·
Decision Jun 8, 1987
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
50
Review Days
63
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Basic Information
- Device Name
- OXIMETER
- K Number
- K871353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Radiometer America, Inc.
- Date Received
- April 6, 1987
- Decision Date
- June 8, 1987
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Radiometer America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Jan 28, 2016 | Substantially Equivalent |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | Jan 10, 2000 | Substantially Equivalent |
| K991417 | ABL 735 ANALYZER | Nov 24, 1999 | Substantially Equivalent |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | Jan 6, 1999 | Substantially Equivalent |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | Feb 9, 1998 | Substantially Equivalent |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Jan 28, 1998 | Substantially Equivalent |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Jan 16, 1998 | Substantially Equivalent |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Oct 6, 1997 | Substantially Equivalent |
| K962158 | PICO MODELS 30, 50, 70 | Oct 29, 1996 | Substantially Equivalent |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | Oct 24, 1996 | Substantially Equivalent |