510(k) K810148
K810148 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "ATMOSET". The FDA issued a decision of Substantially Equivalent on February 17, 1981. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1981
- Date Received
- January 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Examining/Treatment, Ent
- Device Class
- Class I
- Regulation Number
- 874.5300
- Review Panel
- EN
- Submission Type