The following data is part of a premarket notification filed by Konigsberg Instruments, Inc. with the FDA for Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 And P50.
| Device ID | K980980 |
| 510k Number | K980980 |
| Device Name: | MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | KONIGSBERG INSTRUMENTS, INC. 2000 FOOTHILL BLVD. Pasadena, CA 91107 |
| Contact | Arlin Hanson |
| Correspondent | Arlin Hanson KONIGSBERG INSTRUMENTS, INC. 2000 FOOTHILL BLVD. Pasadena, CA 91107 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-06-15 |