The following data is part of a premarket notification filed by Micos Medical Systems with the FDA for Micos Micropulse(tm) Alternating Pressure Mattress.
| Device ID | K945629 |
| 510k Number | K945629 |
| Device Name: | MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS |
| 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 | 1994-11-16 |
| Decision Date | 1995-04-14 |