The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Orthoceph Oc100 D.
Device ID | K001439 |
510k Number | K001439 |
Device Name: | ORTHOCEPH OC100 D |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
Contact | Tommi Jokiniemi |
Correspondent | Tommi Jokiniemi INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-08 |
Decision Date | 2000-06-22 |