The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll Fully Automatic Aed Plus.
| Device ID | K120406 |
| 510k Number | K120406 |
| Device Name: | ZOLL FULLY AUTOMATIC AED PLUS |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Tanmay B Shukla |
| Correspondent | Tanmay B Shukla ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-09 |
| Decision Date | 2012-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946099381 | K120406 | 000 |
| 00847946002183 | K120406 | 000 |
| 00847946002190 | K120406 | 000 |
| 00847946002206 | K120406 | 000 |
| 00847946002213 | K120406 | 000 |
| 00847946002220 | K120406 | 000 |
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| 00847946002244 | K120406 | 000 |
| 00847946002251 | K120406 | 000 |
| 00847946002176 | K120406 | 000 |
| 00847946002169 | K120406 | 000 |
| 00847946099435 | K120406 | 000 |
| 04560233596269 | K120406 | 000 |
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| 04560233596016 | K120406 | 000 |
| 04560233596030 | K120406 | 000 |
| 04560233596405 | K120406 | 000 |
| 00847946002145 | K120406 | 000 |
| 00847946002152 | K120406 | 000 |
| 00847946006860 | K120406 | 000 |
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| 00847946024291 | K120406 | 000 |
| 00847946024468 | K120406 | 000 |
| 00847946024475 | K120406 | 000 |
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| 00847946006914 | K120406 | 000 |
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| 00847946006938 | K120406 | 000 |
| 00847946015091 | K120406 | 000 |
| 00847946015107 | K120406 | 000 |
| 00847946099428 | K120406 | 000 |