The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll Propaq Md.
Device ID | K112761 |
510k Number | K112761 |
Device Name: | ZOLL PROPAQ MD |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Charles W Kolifrath |
Correspondent | Charles W Kolifrath ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | MKJ |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DRO |
Subsequent Product Code | DRT |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | LDD |
Subsequent Product Code | LIX |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-22 |
Decision Date | 2012-04-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847946099633 | K112761 | 000 |
00847946017712 | K112761 | 000 |
00847946017705 | K112761 | 000 |
00847946017699 | K112761 | 000 |
00847946017682 | K112761 | 000 |
00847946017675 | K112761 | 000 |
00847946017668 | K112761 | 000 |
00847946017651 | K112761 | 000 |
00847946017644 | K112761 | 000 |
00847946026646 | K112761 | 000 |
00847946017729 | K112761 | 000 |
00847946020033 | K112761 | 000 |
00847946020156 | K112761 | 000 |
00847946099459 | K112761 | 000 |
00847946026332 | K112761 | 000 |
00847946020224 | K112761 | 000 |
00847946020217 | K112761 | 000 |
00847946020200 | K112761 | 000 |
00847946020194 | K112761 | 000 |
00847946020187 | K112761 | 000 |
00847946020170 | K112761 | 000 |
00847946020163 | K112761 | 000 |
00847946026639 | K112761 | 000 |