The following data is part of a premarket notification filed by E-care Technology Corporation with the FDA for E-care Infared Ear Thermometer, Model Lct-200.
| Device ID | K021753 |
| 510k Number | K021753 |
| Device Name: | E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | E-CARE TECHNOLOGY CORPORATION 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk E-CARE TECHNOLOGY CORPORATION 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-08-06 |
| Summary: | summary |