The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Cutaneous Pressure Plethysmograph.
Device ID | K822522 |
510k Number | K822522 |
Device Name: | CUTANEOUS PRESSURE PLETHYSMOGRAPH |
Classification | Plethysmograph, Impedance |
Applicant | LIFE SCIENCES MANUFACTURING, INC. NH |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-23 |
Decision Date | 1982-09-28 |