The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Elmed Pneumomat Digital.
| Device ID | K905417 |
| 510k Number | K905417 |
| Device Name: | ELMED PNEUMOMAT DIGITAL |
| Classification | Insufflator, Laparoscopic |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Karl Hausner |
| Correspondent | Karl Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-01-31 |