The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Dxpress, Model Lsr2000.
Device ID | K050955 |
510k Number | K050955 |
Device Name: | LIFESIGN DXPRESS, MODEL LSR2000 |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Contact | Kyung-ah Kim |
Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-15 |
Decision Date | 2006-01-23 |
Summary: | summary |