The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2860 Pressure Meter.
| Device ID | K891540 |
| 510k Number | K891540 |
| Device Name: | EDENTEC MODEL 2860 PRESSURE METER |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Gary Syring |
| Correspondent | Gary Syring EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-06-01 |