The following data is part of a premarket notification filed by Instrumed, Inc. with the FDA for Accuflate Accessorie Cart W/iv Pole And Clamp.
| Device ID | K924373 |
| 510k Number | K924373 |
| Device Name: | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP |
| Classification | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
| Applicant | INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
| Contact | Jerry L Spence |
| Correspondent | Jerry L Spence INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
| Product Code | BZN |
| CFR Regulation Number | 868.6175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-28 |
| Decision Date | 1992-11-25 |