TMO INTEGRATED CIRCUIT SYSTEM
FDA 510(k) clearance K820406 · decided 1982-03-02
Clearance details
- K-number
- K820406
- Device name
- TMO INTEGRATED CIRCUIT SYSTEM
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-12
- Decision date
- 1982-03-02
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- KRI
- Device class
- 1
- Regulation number
- 870.4200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| TUBE GRIP (K922404) | Georgia Medical Products, Inc. | 1992-11-23 |
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| CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893) | American Omni Medical, Inc. | 1989-01-30 |
| CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640) | American Omni Medical, Inc. | 1989-01-24 |
| HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605) | Mallinckrodt Critical Care | 1988-02-02 |
| CPE 2000 CARDIO PULMONARY ERGOMETER (K874925) | Medical Graphics Corp. | 1988-01-19 |
| STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890) | Shiley, Inc. | 1987-02-19 |
Recalls involving this device
No recalls on record reference this clearance.