The following data is part of a premarket notification filed by N.m. Beale Co. Inc. with the FDA for Balloon For Ultrasonic Endoscopes.
| Device ID | K992178 |
| 510k Number | K992178 |
| Device Name: | BALLOON FOR ULTRASONIC ENDOSCOPES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | N.M. BEALE CO. INC. 89 OLD SHIRLEY RD. Harvard, MA 01451 |
| Contact | Nathaniel M Beale |
| Correspondent | Nathaniel M Beale N.M. BEALE CO. INC. 89 OLD SHIRLEY RD. Harvard, MA 01451 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 2000-05-12 |