The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign, Care Point, Vitalsign, Accusign.
| Device ID | K944325 |
| 510k Number | K944325 |
| Device Name: | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1995-02-22 |