510(k) K864158
K864158 is an FDA 510(k) premarket notification submitted by Avail-Southwest Division for the device "THERMAPAD". The FDA issued a decision of Substantially Equivalent on March 2, 1987. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Avail-Southwest Division has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1987
- Date Received
- October 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bedding, Disposable, Medical
- Device Class
- Class I
- Regulation Number
- 880.6060
- Review Panel
- HO
- Submission Type