The following data is part of a premarket notification filed by Adams Electronics, Inc. with the FDA for Pediatric Ingestascan.
Device ID | K003305 |
510k Number | K003305 |
Device Name: | PEDIATRIC INGESTASCAN |
Classification | Locator, Metal, Electronic |
Applicant | ADAMS ELECTRONICS, INC. 110 A SUNSET PLAZA PMB 311 Enid, OK 73703 |
Contact | Robert E Adams |
Correspondent | Robert E Adams ADAMS ELECTRONICS, INC. 110 A SUNSET PLAZA PMB 311 Enid, OK 73703 |
Product Code | HPM |
CFR Regulation Number | 886.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-20 |
Decision Date | 2000-12-22 |