SENSI-CAL AMCO AEPA-1
FDA 510(k) clearance K935566 · decided 1994-03-29
Clearance details
- K-number
- K935566
- Device name
- SENSI-CAL AMCO AEPA-1
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-18
- Decision date
- 1994-03-29
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- LIE
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004) | Radiometer America, Inc. | 1986-02-21 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003) | Radiometer America, Inc. | 1985-02-22 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002) | Radiometer America, Inc. | 1984-03-01 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001) | Radiometer America, Inc. | 1981-09-21 |