Pulse Cuff Recorder Model PCR100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K863702 FDA 510(k)
- FDA Product Code
- JOM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2780 FDA 510(k)
- Regulation Number
- 870.2780 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulse Cuff Recorder Model PCR100 is a plethysmograph device that operates using photoelectric, pneumatic or hydraulic technology. It is designed for cardiovascular applications and records pulse data through a cuff mechanism.
This device is manufactured by Imex Medical Systems, Inc. and is supplied as a Class II medical device. It received FDA 510(k) clearance with number K863702 on June 12, 1987, and is registered under product code JOM. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Pulse Cuff Recorder Model PCR100 used for?
The Pulse Cuff Recorder Model PCR100 is a plethysmograph device designed for cardiovascular applications. It operates using photoelectric, pneumatic or hydraulic technology to record pulse data through a cuff mechanism.
Is the Pulse Cuff Recorder Model PCR100 single-use or reusable?
The device data does not specify whether the Pulse Cuff Recorder Model PCR100 is single-use or reusable. No information regarding sterility or MRI safety is provided in the available data.
What is the regulatory status of the Pulse Cuff Recorder Model PCR100?
The Pulse Cuff Recorder Model PCR100 is a Class II medical device that received FDA 510(k) clearance with number K863702 on June 12, 1987. It is registered under product code JOM and manufactured by Imex Medical Systems, Inc.
What are the specifications of the Pulse Cuff Recorder Model PCR100?
The Pulse Cuff Recorder Model PCR100 operates using photoelectric, pneumatic or hydraulic technology. It is designed for cardiovascular applications and records pulse data through a cuff mechanism. The device is manufactured by Imex Medical Systems, Inc. and supplied as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K863702 FDA 510 (k) - PULSE CUFF RECORDER MODEL PCR100, PULSE CUFF RECORDER MODEL PCR100 (K863702) — FDA 510 (k) | Innolitics, 510(k) K863702 — PULSE CUFF RECORDER MODEL PCR100, PDF K863702 - Pulse Cuff Recorder Model Pcr100, Pulse Cuff Recorder Model Pcr100 510 (k) FDA Premarket Notification ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863702 | Class II | Active |
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Manufacturer
- Manufacturer
- Imex Medical Systems, Inc.
Sources (1)
- FDA 510(k) K863702 24 fields · synced Sep 21, 2026