The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for E-20 Rapid Cuff Inflator.
Device ID | K905367 |
510k Number | K905367 |
Device Name: | E-20 RAPID CUFF INFLATOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Contact | Eugene Hokanson |
Correspondent | Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-27 |
Decision Date | 1991-03-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817065021273 | K905367 | 000 |
00817065021266 | K905367 | 000 |
00817065021259 | K905367 | 000 |
00817065021242 | K905367 | 000 |
00817065021235 | K905367 | 000 |
00817065021228 | K905367 | 000 |