The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Mvl/modulab With Pvr Module.
Device ID | K884624 |
510k Number | K884624 |
Device Name: | MVL/MODULAB WITH PVR MODULE |
Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | Campbell, Md |
Correspondent | Campbell, Md LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Product Code | JOM |
CFR Regulation Number | 870.2780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-04 |
Decision Date | 1989-02-01 |