The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Luer Design Thermistors & Capiox Connectors.
| Device ID | K852087 |
| 510k Number | K852087 |
| Device Name: | CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Harold Jacoby |
| Correspondent | Harold Jacoby TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-06-27 |