The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for Hri 6500, 6600 And 6700 Series V2masks.
| Device ID | K071149 |
| 510k Number | K071149 |
| Device Name: | HRI 6500, 6600 AND 6700 SERIES V2MASKS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HANS RUDOLPH, INC. 7205 CENTRAL Kansas City, MO 64114 |
| Contact | Kevin Rudolph |
| Correspondent | Kevin Rudolph HANS RUDOLPH, INC. 7205 CENTRAL Kansas City, MO 64114 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2008-02-01 |
| Summary: | summary |