The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for 4200 Pneumatic Mouth Shutter.
| Device ID | K791705 |
| 510k Number | K791705 |
| Device Name: | 4200 PNEUMATIC MOUTH SHUTTER |
| Classification | Plethysmograph, Pressure |
| Applicant | HANS RUDOLPH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCM |
| CFR Regulation Number | 868.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-28 |
| Decision Date | 1979-10-04 |