CBD · Bottle, Collection, Breathing System (Calibrated)
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | CBD |
|---|---|
| Device Name | Bottle, Collection, Breathing System (Calibrated) |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780340 | IMV SYSTEM | Lkb Instruments, Inc. | Nov 27, 1978 | SESE |
| K770665 | VALVE, PRESSURE, DEMAND | Mcgaw Respiratory Therapy | Apr 15, 1977 | SESE |
| K770369 | VACON TM | Diemolding Corp. | Mar 1, 1977 | SESE |
Top Applicants
- Diemolding Corp. — 1 clearance
- Lkb Instruments, Inc. — 1 clearance
- Mcgaw Respiratory Therapy — 1 clearance
