The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Transesophageal Probe Model 4515.
| Device ID | K892944 |
| 510k Number | K892944 |
| Device Name: | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 |
| Classification | Transducer, Ultrasonic |
| Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Contact | Arthur Schenck |
| Correspondent | Arthur Schenck INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-07-19 |