510(k) K843070
K843070 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "ESOPHAGEAL STETHOSCOPES". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1984
- Date Received
- August 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Esophageal
- Device Class
- Class I
- Regulation Number
- 868.1910
- Review Panel
- AN
- Submission Type