The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Manometer.
| Device ID | K122077 |
| 510k Number | K122077 |
| Device Name: | MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2013-01-10 |
| Summary: | summary |