Modification Manual Resuscitator (PMR 2)
by Puritan Bennett Corp. 510(k)
Active
510(k) K913370
Overview
The Modification Manual Resuscitator (PMR 2) is a manual emergency ventilator device that incorporates a bag and valve to provide emergency respiratory support. It is designed to deliver air to a patient's lungs through a face mask or a tube inserted into the airway.
This device is supplied by Puritan Bennett Corp. and is classified as a Class 2 medical device with FDA 510(k) clearance K913370. It is intended for use in emergency situations where mechanical ventilation is required, and it is regulated under product code BTM.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913370 | Date26 Aug 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the PMR 2 Manual Resuscitator used for?
The PMR 2 is a manual emergency ventilator designed to deliver air to a patient's lungs through a face mask or tube inserted into the airway, providing respiratory support in emergency situations where mechanical ventilation is required.
How is the PMR 2 Manual Resuscitator supplied?
The PMR 2 Manual Resuscitator is supplied by Puritan Bennett Corp. as a Class 2 medical device with FDA 510(k) clearance K913370, regulated under product code BTM for emergency respiratory support.
Is the PMR 2 Manual Resuscitator reusable or single-use?
The device description does not specify whether the PMR 2 is designed for single-use or reuse. Users should refer to the manufacturer's instructions for proper handling and disposal guidelines specific to this model.
What are the regulatory requirements for the PMR 2 Manual Resuscitator?
The PMR 2 is classified as a Class 2 medical device with FDA 510(k) clearance K913370, indicating it has been determined to be substantially equivalent to existing devices and is regulated under product code BTM.