The following data is part of a premarket notification filed by Emergent Technology Corp. with the FDA for Emergent Technology Ventilatory Effort Monitor Vem.
Device ID | K853252 |
510k Number | K853252 |
Device Name: | EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM |
Classification | Monitor, Breathing Frequency |
Applicant | EMERGENT TECHNOLOGY CORP. 14 CODDING RD. Attleboro, MA 02703 |
Contact | William A Morton |
Correspondent | William A Morton EMERGENT TECHNOLOGY CORP. 14 CODDING RD. Attleboro, MA 02703 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-02 |
Decision Date | 1986-01-21 |