BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
FDA 510(k) clearance K901548 · decided 1991-01-14
Clearance details
- K-number
- K901548
- Device name
- BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-03
- Decision date
- 1991-01-14
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- CCC
- Device class
- 2
- Regulation number
- 868.1150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shiley
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |