The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ec6 Plethysmograph.
Device ID | K982707 |
510k Number | K982707 |
Device Name: | EC6 PLETHYSMOGRAPH |
Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Contact | D. Eugene Hokanson |
Correspondent | D. Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Product Code | JOM |
CFR Regulation Number | 870.2780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-03 |
Decision Date | 1998-08-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817065021297 | K982707 | 000 |
00817065021280 | K982707 | 000 |