MULTI-PULSE 2000
Unit, X-ray, Extraoral With Timer
IMAGING SCIENCES INTL., INC.
The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for Multi-pulse 2000.
Pre-market Notification Details
| Device ID | K001248 |
| 510k Number | K001248 |
| Device Name: | MULTI-PULSE 2000 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Contact | Robert E Hay |
| Correspondent | Robert E Hay IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-05-04 |
Trademark Results [MULTI-PULSE 2000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTI-PULSE 2000 76084172 not registered Dead/Abandoned |
J. MORITA USA, INC. 2000-07-03 |
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