The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Autoclavable Internal Handles.
| Device ID | K032691 |
| 510k Number | K032691 |
| Device Name: | ZOLL AUTOCLAVABLE INTERNAL HANDLES |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Paul Dias |
| Correspondent | Paul Dias ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-11-13 |