The following data is part of a premarket notification filed by Mallinckrodt Anesthesia Products with the FDA for Model 4070 Temperature Monitor.
| Device ID | K895875 |
| 510k Number | K895875 |
| Device Name: | MODEL 4070 TEMPERATURE MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MALLINCKRODT ANESTHESIA PRODUCTS ST. LOUIS BUSINESS CENTER 500 SOUTH EWING St. Louis, MO 63103 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman MALLINCKRODT ANESTHESIA PRODUCTS ST. LOUIS BUSINESS CENTER 500 SOUTH EWING St. Louis, MO 63103 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-04 |
| Decision Date | 1989-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521706415 | K895875 | 000 |
| 20884521842844 | K895875 | 000 |
| 20884521842851 | K895875 | 000 |
| 20884521842868 | K895875 | 000 |
| 20884521842875 | K895875 | 000 |
| 20884521842882 | K895875 | 000 |
| 10884521706392 | K895875 | 000 |
| 10884521706422 | K895875 | 000 |
| 10884521706439 | K895875 | 000 |
| 10884521706446 | K895875 | 000 |
| 10884521706408 | K895875 | 000 |
| 20884521842837 | K895875 | 000 |