510(k) K761337
K761337 is an FDA 510(k) premarket notification submitted by Gorman Rupp Industries for the device "AQUAMATIC K-MODULE MODEL K-10". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code JRR (Regulator, Temperature), a Class I device regulated under 21 CFR 862.2050. Gorman Rupp Industries has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1977
- Date Received
- December 27, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Temperature
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type