The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Patient Monitor.
Device ID | K130056 |
510k Number | K130056 |
Device Name: | PATIENT MONITOR |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | LD TECHNOLOGY LLC 100 N. BISCAYNE BLVD, STE 502 Miami, FL 33132 |
Contact | Albert Maarek |
Correspondent | Albert Maarek LD TECHNOLOGY LLC 100 N. BISCAYNE BLVD, STE 502 Miami, FL 33132 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-09 |
Decision Date | 2013-04-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B322B0011 | K130056 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |