The following data is part of a premarket notification filed by Medical Support Products, Inc. with the FDA for Digital Manometer (dm 50).
| Device ID | K901998 |
| 510k Number | K901998 |
| Device Name: | DIGITAL MANOMETER (DM 50) |
| Classification | Meter, Airway Pressure (inspiratory Force) |
| Applicant | MEDICAL SUPPORT PRODUCTS, INC. 3401 CHARLESTOWN RD. Lancaster, PA 17603 |
| Contact | Nelson Shertzer |
| Correspondent | Nelson Shertzer MEDICAL SUPPORT PRODUCTS, INC. 3401 CHARLESTOWN RD. Lancaster, PA 17603 |
| Product Code | BXR |
| CFR Regulation Number | 868.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-07-25 |