510(k) K813298
K813298 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR DELEE HILLIS STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on Dec 8, 1981. The device falls under product code HGN (Stethoscope, Fetal), a Class I device regulated under 21 CFR 884.2900. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 1981
- Date Received
- Nov 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stethoscope, Fetal
- Device Class
- Class I
- Regulation Number
- 884.2900
- Review Panel
- OB
- Submission Type
- 510(k) Exempt