The following data is part of a premarket notification filed by Rozinn Electronics, Inc. with the FDA for Abp For Windows.
Device ID | K021517 |
510k Number | K021517 |
Device Name: | ABP FOR WINDOWS |
Classification | Computer, Blood-pressure |
Applicant | ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385 |
Contact | Mark Rosoff |
Correspondent | Mark Rosoff ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. Glendale, NY 11385 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-10 |
Decision Date | 2002-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856298006176 | K021517 | 000 |