ELC-THERMO-SYSTEM
FDA 510(k) clearance K770678 · decided 1977-05-25
Clearance details
- K-number
- K770678
- Device name
- ELC-THERMO-SYSTEM
- Applicant
- Cutter Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-11
- Decision date
- 1977-05-25
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- KXZ
- Device class
- 3
- Regulation number
- 884.2982
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NOVATHERM (K851034) | Medtech Products, Inc. | 1985-09-27 |
| Q-SCAN THERMOGRAPHY SYSTEM (K843124) | Qmax Medical, Inc. | 1984-11-29 |
| BREAST & BODY HEALTH SYSTEM 2000 (K832731) | American Thermal Instruments, Inc. | 1984-01-30 |
| THERMASCAN (K813547) | Bcd Products, Inc. | 1982-03-12 |
| FLEXT-THERM (K781916) | E-Z-Em, Inc. | 1979-02-02 |
| FLEXI-THERM FILM (K770986) | E-Z-Em, Inc. | 1977-09-12 |
Recalls involving this device
No recalls on record reference this clearance.