The following data is part of a premarket notification filed by Neurotherm, Inc. with the FDA for Nt 2000 Lesioning Generator.
Device ID | K111576 |
510k Number | K111576 |
Device Name: | NT 2000 LESIONING GENERATOR |
Classification | Generator, Lesion, Radiofrequency |
Applicant | NEUROTHERM, INC. 200 Homer Ave Ashland, MA 01721 |
Contact | F. David Rothkopf |
Correspondent | F. David Rothkopf NEUROTHERM, INC. 200 Homer Ave Ashland, MA 01721 |
Product Code | GXD |
CFR Regulation Number | 882.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-06 |
Decision Date | 2011-09-20 |
Summary: | summary |