510(k) K810588
K810588 is an FDA 510(k) premarket notification submitted by Brattle Instrument Corp. for the device "SYNCHRONIZER #208". The FDA issued a decision of Substantially Equivalent on April 10, 1981. The device falls under product code IXO (Synchronizer, Ecg / Respirator, Radiographic), a Class I device regulated under 21 CFR 892.1970. Brattle Instrument Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1981
- Date Received
- March 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Ecg / Respirator, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1970
- Review Panel
- RA
- Submission Type