510(k) K780510
K780510 is an FDA 510(k) premarket notification submitted by Bios, Inc. for the device "NUCLEAR STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code IYY (Synchronizer, Electrocardiograph, Nuclear), a Class I device regulated under 21 CFR 892.1410. Bios, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1978
- Date Received
- March 30, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Electrocardiograph, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1410
- Review Panel
- RA
- Submission Type