The following data is part of a premarket notification filed by Intl. Medical Equipment Corp. with the FDA for Mattress, Air Floatation, Altern. Press..
Device ID | K803307 |
510k Number | K803307 |
Device Name: | MATTRESS, AIR FLOATATION, ALTERN. PRESS. |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | INTL. MEDICAL EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-30 |
Decision Date | 1981-01-13 |