510(k) K801185
K801185 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR BOWLS STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on Jun 4, 1980. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 4, 1980
- Date Received
- May 19, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stethoscope, Manual
- Device Class
- Class I
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k) Exempt