The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Clinical Electronic Thermometer, Models Tp11403 Through Tp11413.
| Device ID | K070342 |
| 510k Number | K070342 |
| Device Name: | CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Harmans, MD 21077 |
| Contact | John Taylor |
| Correspondent | John Taylor AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Harmans, MD 21077 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-03-19 |
| Summary: | summary |