MEC · Disinfector, Medical Devices
General Hospital · 21 CFR 880.6992 · Class 2
Overview
| Product Code | MEC |
|---|---|
| Device Name | Disinfector, Medical Devices |
| Regulation | 21 CFR 880.6992 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. (2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Olympic Medical Corp. | Jun 20, 2008 | SESE |
| K911120 | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 | Hamo USA, Inc. | Feb 3, 1994 | SESE |
Top Applicants
- Hamo USA, Inc. — 1 clearance
- Olympic Medical Corp. — 1 clearance
