BLOOD GAS EXPERSYSTEM 8700
FDA 510(k) clearance K833430 · decided 1984-02-10
Clearance details
- K-number
- K833430
- Device name
- BLOOD GAS EXPERSYSTEM 8700
- Applicant
- Medical Intelcom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-05
- Decision date
- 1984-02-10
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- LLE
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Intelcom
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 |
|---|---|---|
| INIVOX ELECTRODE/CATHETER SYS (K832916) | Critikon Company, LLC | 1983-11-14 |
Recalls involving this device
No recalls on record reference this clearance.