The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for Spectrum Spirit.
Device ID | K983763 |
510k Number | K983763 |
Device Name: | SPECTRUM SPIRIT |
Classification | Wheelchair, Mechanical |
Applicant | FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065 |
Contact | Ginny S Maloco |
Correspondent | Ginny S Maloco FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-26 |
Decision Date | 1998-11-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841447101376 | K983763 | 000 |