The following data is part of a premarket notification filed by Alternative Design Systems, Inc. with the FDA for Stratum D.
| Device ID | K874697 |
| 510k Number | K874697 |
| Device Name: | STRATUM D |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Contact | Orlando, Iii |
| Correspondent | Orlando, Iii ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-19 |
| Decision Date | 1987-12-15 |