The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Nerve Integrity Monitor-2 (nim-2 Xl).
Device ID | K934426 |
510k Number | K934426 |
Device Name: | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) |
Classification | Stimulator, Nerve |
Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
Contact | Terry C Mcmahon |
Correspondent | Terry C Mcmahon XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-10 |
Decision Date | 1994-05-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20763000040738 | K934426 | 000 |
20763000038407 | K934426 | 000 |
20763000040714 | K934426 | 000 |
00721902669811 | K934426 | 000 |
00721902669835 | K934426 | 000 |
20681490176662 | K934426 | 000 |
20681490176686 | K934426 | 000 |
20681490176709 | K934426 | 000 |
20681490176716 | K934426 | 000 |
20885074472915 | K934426 | 000 |
20763000041377 | K934426 | 000 |
20763000040769 | K934426 | 000 |
00763000033781 | K934426 | 000 |
00763000034146 | K934426 | 000 |
00763000036379 | K934426 | 000 |
20763000038391 | K934426 | 000 |
20763000040707 | K934426 | 000 |
20763000040721 | K934426 | 000 |
20763000040745 | K934426 | 000 |
20763000040752 | K934426 | 000 |
20681490176723 | K934426 | 000 |
00681490176750 | K934426 | 000 |
00681490176767 | K934426 | 000 |
20643169938407 | K934426 | 000 |
20643169938414 | K934426 | 000 |
20643169938421 | K934426 | 000 |
20643169938469 | K934426 | 000 |
00643169938472 | K934426 | 000 |
00643169938496 | K934426 | 000 |
00643169938830 | K934426 | 000 |
20643169939084 | K934426 | 000 |
20643169938391 | K934426 | 000 |
20643169938353 | K934426 | 000 |
20643169938346 | K934426 | 000 |
20681490176778 | K934426 | 000 |
20681490176785 | K934426 | 000 |
20643169344949 | K934426 | 000 |
00643169344952 | K934426 | 000 |
20643169431106 | K934426 | 000 |
20643169431113 | K934426 | 000 |
20643169938322 | K934426 | 000 |
20643169938339 | K934426 | 000 |
00613994431585 | K934426 | 000 |