The following data is part of a premarket notification filed by Moss Rehabilation Hospital with the FDA for Moss Limb Load Monitor Lm101-1.
Device ID | K844202 |
510k Number | K844202 |
Device Name: | MOSS LIMB LOAD MONITOR LM101-1 |
Classification | Transducer, Miniature Pressure |
Applicant | MOSS REHABILATION HOSPITAL 12TH. ST. & TABOR RD. PHILADELPHIA, PA 19141 |
Contact | HARRIET A LUSKIN |
Correspondent | HARRIET A LUSKIN MOSS REHABILATION HOSPITAL 12TH. ST. & TABOR RD. PHILADELPHIA, PA 19141 |
Product Code | IKE |
CFR Regulation Number | 890.1615 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-30 |
Decision Date | 1984-11-27 |