The following data is part of a premarket notification filed by Ascom (sweden) Ab with the FDA for Ascom Mobile Monitoring Gateway (mmg).
| Device ID | K111215 |
| 510k Number | K111215 |
| Device Name: | ASCOM MOBILE MONITORING GATEWAY (MMG) |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | ASCOM (SWEDEN) AB GRIMBODALEN 2, P.O. BOX 8783 Goteborg, SE Se-402-76 |
| Contact | Tania Ottebrink |
| Correspondent | Tania Ottebrink ASCOM (SWEDEN) AB GRIMBODALEN 2, P.O. BOX 8783 Goteborg, SE Se-402-76 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350088670009 | K111215 | 000 |