The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Smartpads Iii.
| Device ID | K072812 |
| 510k Number | K072812 |
| Device Name: | PHILIPS HEARTSTART SMARTPADS III |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Contact | Larry Walker |
| Correspondent | Larry Walker PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-01 |
| Decision Date | 2008-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838023772 | K072812 | 000 |
| 00884838023765 | K072812 | 000 |