The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for A-v Recorder.
Device ID | K873041 |
510k Number | K873041 |
Device Name: | A-V RECORDER |
Classification | Probe, Blood-flow, Extravascular |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | James H Vezina |
Correspondent | James H Vezina LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1988-02-04 |