The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for Directional Control Valves Inflatable Balloon-type And Controllers.
| Device ID | K946077 |
| 510k Number | K946077 |
| Device Name: | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
| Contact | Kevin Rudolph |
| Correspondent | Kevin Rudolph HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-09-15 |