Modification 7200 Microprocessor Ventilator System
by Puritan Bennett Corp. 510(k)
Active
510(k) K854070
Overview
The Modification 7200 Microprocessor Ventilator System is a continuous ventilator designed for facility use. It is a Class II medical device with product code CBK, classified under special controls. The system utilizes microprocessor technology to provide ventilatory support in clinical settings.
This device is manufactured by Puritan Bennett Corp. and received FDA 510(k) clearance on February 14, 1986, with K number K854070. It is intended for facility use and is not specified as single-use or reusable. The system is not indicated as MRI safe, and specific size options are not detailed in the provided information.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854070 | Date14 Feb 1986 | 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- Withdrawn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
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the Modification 7200 Microprocessor Ventilator System used for?
The Modification 7200 Microprocessor Ventilator System is designed for facility use to provide ventilatory support in clinical settings. It utilizes microprocessor technology to assist patients with breathing difficulties in a hospital or clinical environment.
Is the Modification 7200 Ventilator System single-use or reusable?
The device is not specified as single-use or reusable in the provided information. It is designed for facility use, which typically suggests it may be intended for multiple patients within a healthcare setting, but specific reuse guidelines are not detailed in the available data.
What is the regulatory status of the Modification 7200 Ventilator System?
The Modification 7200 Microprocessor Ventilator System received FDA 510(k) clearance on February 14, 1986, with K number K854070. It is classified as a Class II medical device with product code CBK under special controls. The device is substantially equivalent to predicate devices in this category.
Is the Modification 7200 Ventilator System MRI safe?
The provided information does not indicate that the Modification 7200 Microprocessor Ventilator System is MRI safe. Healthcare providers should consult the manufacturer's documentation or contact Puritan Bennett Corp. for specific guidance regarding MRI compatibility before use in such environments.