The following data is part of a premarket notification filed by Schiller Medical S.a. with the FDA for Maglife C/maglife C Plus.
| Device ID | K023195 |
| 510k Number | K023195 |
| Device Name: | MAGLIFE C/MAGLIFE C PLUS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SCHILLER MEDICAL S.A. 4 RUE LOUIS PASTEUR ZAE SUD BP 90050 Wissembourg Cedex, FR 67162 |
| Contact | Court Goehry |
| Correspondent | Court Goehry SCHILLER MEDICAL S.A. 4 RUE LOUIS PASTEUR ZAE SUD BP 90050 Wissembourg Cedex, FR 67162 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2003-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365900132 | K023195 | 000 |
| 07613365900019 | K023195 | 000 |
| 07613365900026 | K023195 | 000 |
| 07613365900033 | K023195 | 000 |
| 07613365900040 | K023195 | 000 |
| 07613365900057 | K023195 | 000 |
| 07613365900064 | K023195 | 000 |
| 07613365900071 | K023195 | 000 |
| 07613365900088 | K023195 | 000 |
| 07613365900101 | K023195 | 000 |
| 07613365900118 | K023195 | 000 |
| 07613365900125 | K023195 | 000 |
| 07613365900002 | K023195 | 000 |