The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Nc Sp02 Adapter Cable.
Device ID | K041204 |
510k Number | K041204 |
Device Name: | NC SP02 ADAPTER CABLE |
Classification | Oximeter |
Applicant | MASIMO CORP. 40 PARKER Irvine, CA 92618 |
Contact | James J Cronin |
Correspondent | James J Cronin MASIMO CORP. 40 PARKER Irvine, CA 92618 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-07 |
Decision Date | 2004-06-29 |
Summary: | summary |