The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Disposable Sterile Internal Defibrillation Paddles (switched-large), Disposable Sterile Internal Defibrillation Paddles.
| Device ID | K030417 |
| 510k Number | K030417 |
| Device Name: | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Peter Ohanian |
| Correspondent | Peter Ohanian PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-05-09 |
| Summary: | summary |