The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Linear Scanner Probe Elscint Ltd. Tl-35.
Device ID | K844189 |
510k Number | K844189 |
Device Name: | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 |
Classification | Phantom, Anthropomorphic, Nuclear |
Applicant | ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Contact | Robert E Kenney |
Correspondent | Robert E Kenney ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Product Code | IYP |
CFR Regulation Number | 892.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-30 |
Decision Date | 1985-02-25 |