The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Ipg-ii Module.
Device ID | K903700 |
510k Number | K903700 |
Device Name: | IPG-II MODULE |
Classification | Plethysmograph, Impedance |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | Robert S Cutler |
Correspondent | Robert S Cutler LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-15 |
Decision Date | 1991-01-16 |