RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
FDA 510(k) clearance K853848 · decided 1985-12-05
Clearance details
- K-number
- K853848
- Device name
- RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
- Applicant
- Medical Graphics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-16
- Decision date
- 1985-12-05
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- BXW
- Device class
- 1
- Regulation number
- 868.1870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, 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 |
|---|---|---|
| FLOW-CALIBRATION MODULE (K831758) | The Perkin-Elmer Corp. | 1983-07-19 |
| SYRINGE 500BC BE #7000 (K830898) | Instrumentation Industries, Inc. | 1983-05-16 |
| DATASCRIBE #DS-40 (K812765) | Timeter Instrument Corp. | 1981-11-16 |
| OHIO CAL-CHEK (K810290) | Ohio Medical Products | 1981-02-12 |
| CALIPERS, MCGAW SKINFOLD (K760520) | Mcgaw Laboratories | 1976-11-12 |
Recalls involving this device
No recalls on record reference this clearance.