510(k) K800442
K800442 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "VARIOTHERM". The FDA issued a decision of Substantially Equivalent on March 10, 1980. The device falls under product code ETP (Stimulator, Caloric-Water), a Class I device regulated under 21 CFR 874.1800. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1980
- Date Received
- February 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Caloric-Water
- Device Class
- Class I
- Regulation Number
- 874.1800
- Review Panel
- EN
- Submission Type