The following data is part of a premarket notification filed by Mallinckrodt Anesthesia Products with the FDA for Hi-lo Temp General Purpose Temperature Probe.
| Device ID | K890484 |
| 510k Number | K890484 |
| Device Name: | HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MALLINCKRODT ANESTHESIA PRODUCTS HOOK RD. Argyle, NY 12809 |
| Contact | E Wiegert,phd |
| Correspondent | E Wiegert,phd MALLINCKRODT ANESTHESIA PRODUCTS HOOK RD. Argyle, NY 12809 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-31 |
| Decision Date | 1989-04-21 |