The following data is part of a premarket notification filed by Neoforce Group Inc with the FDA for Pressure Manometer.
Device ID | K110119 |
510k Number | K110119 |
Device Name: | PRESSURE MANOMETER |
Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | NEOFORCE GROUP INC 35 COMMERCE DRIVE Ivyland, PA 18974 |
Contact | Monica Ferrante |
Correspondent | Monica Ferrante NEOFORCE GROUP INC 35 COMMERCE DRIVE Ivyland, PA 18974 |
Product Code | CAP |
CFR Regulation Number | 868.2600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-18 |
Decision Date | 2011-06-10 |
Summary: | summary |