The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Electronic Thermometers.
| Device ID | K940686 |
| 510k Number | K940686 |
| Device Name: | ELECTRONIC THERMOMETERS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AMERICAN DIAGNOSTIC CORP. 93 A OTIS ST. West Babylon, NY 11704 |
| Contact | Marc Blitstein |
| Correspondent | Marc Blitstein AMERICAN DIAGNOSTIC CORP. 93 A OTIS ST. West Babylon, NY 11704 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-16 |
| Decision Date | 1994-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040000905 | K940686 | 000 |
| 00634782553395 | K940686 | 000 |
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| 00634782553463 | K940686 | 000 |
| 00634782553432 | K940686 | 000 |
| 20607415001192 | K940686 | 000 |