The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ec 5r Plethysmograph.
Device ID | K932812 |
510k Number | K932812 |
Device Name: | EC 5R PLETHYSMOGRAPH |
Classification | Plethysmograph, Volume |
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 | JEH |
CFR Regulation Number | 868.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1994-01-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817065022478 | K932812 | 000 |
00817065021440 | K932812 | 000 |