The following data is part of a premarket notification filed by Zoll Manufacturing Corporation with the FDA for Zoll Ecg Analysis Software.
| Device ID | K182093 |
| 510k Number | K182093 |
| Device Name: | ZOLL ECG Analysis Software |
| Classification | Electrocardiograph |
| Applicant | ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh, PA 15238 |
| Contact | Zachary Nelson |
| Correspondent | Zachary Nelson ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh, PA 15238 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2019-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855778005333 | K182093 | 000 |