The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Carryall Enhancements.
| Device ID | K943931 |
| 510k Number | K943931 |
| Device Name: | CARRYALL ENHANCEMENTS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. 7431 N.E. EVERGREEN PKWY., ONE TECHNOLOGY CENTER Hillsboro, OR 97124 -5898 |
| Contact | Herbert J Semler |
| Correspondent | Herbert J Semler INSTROMEDIX, INC. 7431 N.E. EVERGREEN PKWY., ONE TECHNOLOGY CENTER Hillsboro, OR 97124 -5898 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1995-04-04 |