The following data is part of a premarket notification filed by Magna-lab, Inc. with the FDA for Magna Sl.
Device ID | K940894 |
510k Number | K940894 |
Device Name: | MAGNA SL |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MAGNA-LAB, INC. 950 SOUTH OYSTER BAY RD. Hicksville, NY 11801 |
Contact | John D Haytaian |
Correspondent | John D Haytaian MAGNA-LAB, INC. 950 SOUTH OYSTER BAY RD. Hicksville, NY 11801 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-24 |
Decision Date | 1994-09-02 |