The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Portable Air Plethysmograph.
Device ID | K895588 |
510k Number | K895588 |
Device Name: | PORTABLE AIR PLETHYSMOGRAPH |
Classification | Plethysmograph, Impedance |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | Glyn Green |
Correspondent | Glyn Green 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 | 1989-09-15 |
Decision Date | 1990-03-27 |