The following data is part of a premarket notification filed by Neuromechanical Innovations, Llc with the FDA for Impulse Iq Adjusting Instrument.
Device ID | K080261 |
510k Number | K080261 |
Device Name: | IMPULSE IQ ADJUSTING INSTRUMENT |
Classification | Manipulator, Plunger-like Joint |
Applicant | NEUROMECHANICAL INNOVATIONS, LLC 11011 SOUTH 48TH ST., STE. 220 Phoenix, AZ 85044 |
Contact | Christopher J Colloca |
Correspondent | Christopher J Colloca NEUROMECHANICAL INNOVATIONS, LLC 11011 SOUTH 48TH ST., STE. 220 Phoenix, AZ 85044 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-01 |
Decision Date | 2008-04-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860011416418 | K080261 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMPULSE IQ ADJUSTING INSTRUMENT 77563701 3665972 Live/Registered |
Neuromechanical Innovations, LLC 2008-09-05 |