The following data is part of a premarket notification filed by Boxview, Llc with the FDA for Smart Alarm Interface.
Device ID | K193421 |
510k Number | K193421 |
Device Name: | Smart Alarm Interface |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | BoxView, LLC 14001 McAuley Blvd. Suite 220 Oklahoma City, OK 73134 |
Contact | Cody Guest |
Correspondent | Robert Steurer Steurer Consulting Group 800 Blue Quail Rd. Keller, TX 76248 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-09 |
Decision Date | 2020-10-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522129216 | K193421 | 000 |