DRAGER ORM
FDA 510(k) clearance K790334 · decided 1979-03-07
Clearance details
- K-number
- K790334
- Device name
- DRAGER ORM
- Applicant
- Draeger Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-16
- Decision date
- 1979-03-07
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- BYR
- Device class
- 1
- Regulation number
- 868.2875
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Draeger Medical
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.
| Record | Firm | Date |
|---|---|---|
| BICORE VARIFLEX(R) FLOW TRANSDUCER (K896718) | Bicore Monitoring Systems | 1990-02-22 |
| MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS (K801880) | Medical Measurements, Inc. | 1980-08-14 |
Recalls involving this device
No recalls on record reference this clearance.