The following data is part of a premarket notification filed by Micos Medical Systems with the FDA for Micos Micropulse(tm) Or Table Patient Support.
Device ID | K945845 |
510k Number | K945845 |
Device Name: | MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | MICOS MEDICAL SYSTEMS 7550 BENDERE Hickory Corners, MI 49060 |
Contact | Jim Tappel |
Correspondent | Jim Tappel MICOS MEDICAL SYSTEMS 7550 BENDERE Hickory Corners, MI 49060 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-30 |
Decision Date | 1995-05-03 |