The following data is part of a premarket notification filed by Lisca Development Ab with the FDA for Pim 1.0 Laser Doppler Perfusion Imager.
Device ID | K920844 |
510k Number | K920844 |
Device Name: | PIM 1.0 LASER DOPPLER PERFUSION IMAGER |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | LISCA DEVELOPMENT AB LOVSBERGSV. 13 Linkoping, SE |
Contact | Gert Nilsson |
Correspondent | Gert Nilsson LISCA DEVELOPMENT AB LOVSBERGSV. 13 Linkoping, SE |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-24 |
Decision Date | 1992-07-21 |