510(k) K992178
K992178 is an FDA 510(k) premarket notification submitted by N.M. Beale Co., Inc. for the device "BALLOON FOR ULTRASONIC ENDOSCOPES". The FDA issued a decision of Substantially Equivalent on May 12, 2000. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. N.M. Beale Co., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2000
- Date Received
- June 28, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type