The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for High Flow Insufflantion Unit.
| Device ID | K122180 |
| 510k Number | K122180 |
| Device Name: | HIGH FLOW INSUFFLANTION UNIT |
| Classification | Insufflator, Laparoscopic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | HIF |
| Subsequent Product Code | FCX |
| Subsequent Product Code | OSV |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2012-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170324147 | K122180 | 000 |
| 04953170305023 | K122180 | 000 |
| 04953170305009 | K122180 | 000 |