The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Ac-1 Adapter Cable, 8 Pin And 12 Pin Philips.
Device ID | K050252 |
510k Number | K050252 |
Device Name: | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS |
Classification | Oximeter |
Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
Contact | James J Cronin |
Correspondent | James J Cronin MASIMO CORPORATION 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 | 2005-02-03 |
Decision Date | 2005-05-11 |
Summary: | summary |