510(k) K812340
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1981
- Date Received
- August 18, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Incubators/Water, All
- Device Class
- Class I
- Regulation Number
- 866.2540
- Review Panel
- MI
- Submission Type