RI 300 DIFFERENTIAL TEMPERATURE MONITOR
FDA 510(k) clearance K822831 · decided 1982-10-28
Clearance details
- K-number
- K822831
- Device name
- RI 300 DIFFERENTIAL TEMPERATURE MONITOR
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-21
- Decision date
- 1982-10-28
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE CHANGERS (P800068/S002) | Instrumentation Industries, Inc. | 1999-11-04 |
| ENDOTRACHEAL TUBE CHANGER (P800068/S001) | Instrumentation Industries, Inc. | 1999-07-23 |
| ENDOTRACHEAL TUBE CHANGER (P800068) | Instrumentation Industries, Inc. | 1981-07-21 |