The following data is part of a premarket notification filed by Medical Products, Inc. with the FDA for Tempo Iii.
| Device ID | K981509 |
| 510k Number | K981509 |
| Device Name: | TEMPO III |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MEDICAL PRODUCTS, INC. 14014 SULLYFIELD CIRCLE, #A Chantilly, VA 20151 |
| Contact | Durward Faries, Jr. |
| Correspondent | Durward Faries, Jr. MEDICAL PRODUCTS, INC. 14014 SULLYFIELD CIRCLE, #A Chantilly, VA 20151 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-28 |
| Decision Date | 1998-07-10 |