The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ec-4 Plethysmograph.
| Device ID | K801291 |
| 510k Number | K801291 |
| Device Name: | EC-4 PLETHYSMOGRAPH |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | D. E. HOKANSON, INC. WA |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-02 |
| Decision Date | 1980-07-08 |