The following data is part of a premarket notification filed by Smith with the FDA for Tempo And Temp H20.
| Device ID | K973748 |
| 510k Number | K973748 |
| Device Name: | TEMPO AND TEMP H20 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | SMITH P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Durward Faries, Jr. |
| Correspondent | Durward Faries, Jr. SMITH P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1998-03-10 |