E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
FDA 510(k) clearance K900333 · decided 1990-04-16
Clearance details
- K-number
- K900333
- Device name
- E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-23
- Decision date
- 1990-04-16
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiometer America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |