The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Infant Thermometer.
| Device ID | K954434 |
| 510k Number | K954434 |
| Device Name: | OLYMPIC INFANT THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph P Stefanile |
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1995-12-20 |