The following data is part of a premarket notification filed by Eischoco, Inc. with the FDA for Intermittent Compressor System.
Device ID | K964957 |
510k Number | K964957 |
Device Name: | INTERMITTENT COMPRESSOR SYSTEM |
Classification | Massager, Powered Inflatable Tube |
Applicant | EISCHOCO, INC. 1232 S.E. 282ND AVE. Gresham, OR 97080 |
Contact | Clement Eischen |
Correspondent | Clement Eischen EISCHOCO, INC. 1232 S.E. 282ND AVE. Gresham, OR 97080 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-11 |
Decision Date | 1997-02-24 |
Summary: | summary |