The following data is part of a premarket notification filed by Arizant Healthcare Inc. with the FDA for Ranger Irrigation Fluid Warming System.
| Device ID | K060939 |
| 510k Number | K060939 |
| Device Name: | RANGER IRRIGATION FLUID WARMING SYSTEM |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | David Westlin |
| Correspondent | David Westlin ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608223297001 | K060939 | 000 |
| 00608223247006 | K060939 | 000 |
| 00707387781873 | K060939 | 000 |
| 00707387781620 | K060939 | 000 |
| 50707387781779 | K060939 | 000 |
| 50608223247506 | K060939 | 000 |
| 50707387803143 | K060939 | 000 |
| 50707387792720 | K060939 | 000 |