SPIROCAL
FDA 510(k) clearance K791294 · decided 1979-08-16
Clearance details
- K-number
- K791294
- Device name
- SPIROCAL
- Applicant
- Equilibrated Bio Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-10
- Decision date
- 1979-08-16
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- BXX
- Device class
- 1
- Regulation number
- 868.2620
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SINGLE DOSE GAS INJECTOR (K923397) | Escalon Medical Trek | 1992-09-14 |
| RT-200 COMPUTER INTERFACE (K875075) | Timeter Instrument Corp. | 1988-04-21 |
| UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL (K850029) | Utah Medical Products, Inc. | 1985-04-29 |
| RT-200 CALIBRATION ANALYZER (K822746) | Timeter Instrument Corp. | 1982-10-13 |
| NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY (K801256) | Kleen Test Products | 1980-06-04 |
| NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. (K801257) | Kleen Test Products | 1980-06-04 |
| NEEDLE COUNTER-SURE COUNT/10 COUNT (K801258) | Kleen Test Products | 1980-06-04 |
| PORTABLE PNEUMATIC CALIBRATOR 65-150 (K780981) | Pennwalt Corp. | 1978-08-02 |
| PERCI (K780838) | Micro Tronics Corp. | 1978-07-17 |
Recalls involving this device
No recalls on record reference this clearance.