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 |