INIVOX ELECTRODE/CATHETER SYS
FDA 510(k) clearance K832916 · decided 1983-11-14
Clearance details
- K-number
- K832916
- Device name
- INIVOX ELECTRODE/CATHETER SYS
- Applicant
- Critikon Company, LLC
- Decision
- Substantially Equivalent
- Date received
- 1983-08-29
- Decision date
- 1983-11-14
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LLE
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- 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 |
|---|---|---|
| BLOOD GAS EXPERSYSTEM 8700 (K833430) | Medical Intelcom, Inc. | 1984-02-10 |
Recalls involving this device
No recalls on record reference this clearance.