The following data is part of a premarket notification filed by Greenleaf Medical Systems, Inc. with the FDA for (dataglove) Hand Impairment Evaluation System.
Device ID | K884723 |
510k Number | K884723 |
Device Name: | (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM |
Classification | Goniometer, Ac-powered |
Applicant | GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto, CA 94306 |
Contact | Seelig, Phd |
Correspondent | Seelig, Phd GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto, CA 94306 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-10 |
Decision Date | 1989-02-08 |