510(k) K873656
K873656 is an FDA 510(k) premarket notification submitted by Medatron, Inc. for the device "MEDATRON CUVETTE DISC". The FDA issued a decision of Substantially Equivalent on December 14, 1987. The device falls under product code JRI (Cuvette, Thermostated), a Class I device regulated under 21 CFR 862.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1987
- Date Received
- September 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuvette, Thermostated
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type