The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 And Fm50.
Device ID | K140535 |
510k Number | K140535 |
Device Name: | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
Classification | System, Monitoring, Perinatal |
Applicant | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
Contact | Michael Asmalsky |
Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
Product Code | HGM |
Subsequent Product Code | DQA |
Subsequent Product Code | DRG |
Subsequent Product Code | DRQ |
Subsequent Product Code | DRS |
Subsequent Product Code | DRT |
Subsequent Product Code | DSA |
Subsequent Product Code | DSF |
Subsequent Product Code | DSI |
Subsequent Product Code | DSJ |
Subsequent Product Code | DSK |
Subsequent Product Code | DXG |
Subsequent Product Code | DXN |
Subsequent Product Code | DXQ |
Subsequent Product Code | FLL |
Subsequent Product Code | HFM |
Subsequent Product Code | HFN |
Subsequent Product Code | HGL |
Subsequent Product Code | JOM |
Subsequent Product Code | MSX |
Subsequent Product Code | &nb |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-04 |
Decision Date | 2014-11-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838034259 | K140535 | 000 |
00884838000407 | K140535 | 000 |
00884838000414 | K140535 | 000 |
00884838000421 | K140535 | 000 |
00884838000438 | K140535 | 000 |
00884838001404 | K140535 | 000 |
00884838001411 | K140535 | 000 |
00884838002715 | K140535 | 000 |
00884838002722 | K140535 | 000 |
00884838009950 | K140535 | 000 |
00884838009974 | K140535 | 000 |
00884838010338 | K140535 | 000 |
00884838012141 | K140535 | 000 |
00884838021471 | K140535 | 000 |
00884838021488 | K140535 | 000 |
00884838034228 | K140535 | 000 |
00884838034235 | K140535 | 000 |
00884838034242 | K140535 | 000 |
20884838059324 | K140535 | 000 |