The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Surveyor S4 Mobile Monitor.
Device ID | K141020 |
510k Number | K141020 |
Device Name: | SURVEYOR S4 MOBILE MONITOR |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
Contact | Amy Yang |
Correspondent | Amy Yang MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-21 |
Decision Date | 2014-12-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00812345027884 | K141020 | 000 |
00812345025903 | K141020 | 000 |
00812345025897 | K141020 | 000 |
00812345025880 | K141020 | 000 |
00812345025873 | K141020 | 000 |
00812345025866 | K141020 | 000 |
00812345025859 | K141020 | 000 |
00812345025842 | K141020 | 000 |
00812345025835 | K141020 | 000 |
00812345025361 | K141020 | 000 |
00812345024661 | K141020 | 000 |
00812345023473 | K141020 | 000 |
00812345025910 | K141020 | 000 |
00812345025927 | K141020 | 000 |
00812345025934 | K141020 | 000 |
00812345027877 | K141020 | 000 |
00812345027860 | K141020 | 000 |
00812345027853 | K141020 | 000 |
00812345027846 | K141020 | 000 |
00812345026009 | K141020 | 000 |
00812345025996 | K141020 | 000 |
00812345025989 | K141020 | 000 |
00812345025972 | K141020 | 000 |
00812345025965 | K141020 | 000 |
00812345025958 | K141020 | 000 |
00812345025941 | K141020 | 000 |
00732094279832 | K141020 | 000 |