The following data is part of a premarket notification filed by Merced Medical, Inc. with the FDA for Thermoprobe 210.
| Device ID | K900569 |
| 510k Number | K900569 |
| Device Name: | THERMOPROBE 210 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MERCED MEDICAL, INC. 113300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Contact | Jeff Ratner |
| Correspondent | Jeff Ratner MERCED MEDICAL, INC. 113300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-04-10 |