The following data is part of a premarket notification filed by Spiess Design, Inc. with the FDA for Co2 Insufflator High Flow Electronic Insufflator.
| Device ID | K920114 |
| 510k Number | K920114 |
| Device Name: | CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
| Contact | Dieter Keppel |
| Correspondent | Dieter Keppel SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-10 |
| Decision Date | 1992-04-06 |