The following data is part of a premarket notification filed by Gorman Rupp Industries with the FDA for Blood/fluid Warmer Model Dw-1000a.
| Device ID | K770232 |
| 510k Number | K770232 |
| Device Name: | BLOOD/FLUID WARMER MODEL DW-1000A |
| Classification | Warmer, Blood, Non-electromagnetic Radiation |
| Applicant | GORMAN RUPP INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSB |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-02-07 |
| Decision Date | 1977-02-14 |