The following data is part of a premarket notification filed by Sierra Scientific Instruments, Inc. with the FDA for Manoscan Motility With Impedance Visualization System.
| Device ID | K091070 |
| 510k Number | K091070 |
| Device Name: | MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SIERRA SCIENTIFIC INSTRUMENTS, INC. 5757 CENTURY BLVD. SUITE 660 Los Angeles, CA 90045 |
| Contact | Reic S Finkelman |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101365709 | K091070 | 000 |
| 04260167482989 | K091070 | 000 |
| 04260167482569 | K091070 | 000 |
| 04260167482552 | K091070 | 000 |
| 04260167482521 | K091070 | 000 |
| 04260167482514 | K091070 | 000 |
| 04260167482507 | K091070 | 000 |
| 04260167482484 | K091070 | 000 |
| 04260167482477 | K091070 | 000 |
| 04260167482460 | K091070 | 000 |
| 04260167482453 | K091070 | 000 |
| 04260167482446 | K091070 | 000 |
| 04260167482439 | K091070 | 000 |
| 04260167482422 | K091070 | 000 |
| 04260167480961 | K091070 | 000 |
| 07290101362678 | K091070 | 000 |
| 07290101362685 | K091070 | 000 |
| 07290101363347 | K091070 | 000 |
| 07290101365655 | K091070 | 000 |
| 07290101365433 | K091070 | 000 |
| 07290101365426 | K091070 | 000 |
| 07290101365396 | K091070 | 000 |
| 07290101364290 | K091070 | 000 |
| 07290101363996 | K091070 | 000 |
| 07290101363989 | K091070 | 000 |
| 07290101363972 | K091070 | 000 |
| 07290101363941 | K091070 | 000 |
| 07290101363699 | K091070 | 000 |
| 07290101363590 | K091070 | 000 |
| 07290101363583 | K091070 | 000 |
| 07290101363545 | K091070 | 000 |
| 07290101363521 | K091070 | 000 |
| 04260167480954 | K091070 | 000 |