MEDIPALM-20
FDA 510(k) K031202 · Braebon Medical Corp.
510(k) numberK031202
Submission
- Device name
- MEDIPALM-20
- Applicant
- Braebon Medical Corp.
Carp, Ontario, CA - Received
- April 16, 2003
- Decision date
- May 1, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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| K173868 | Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional | Neurotronics, Inc. | 07/02/2018SE |
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| K061764 | Medibyte, Model MP8MNR · Traditional | 09/06/2006SE |
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| K984431 | Ultima Airflow Pressure SensorBZQ · Special | 12/30/1998SE |
| K981445 | Ultima Airflow Sensor, 0510BZQ · Traditional | 10/05/1998SE |
| K982216 | Ultima Respiratory Effort Sensor Models 0520 and 0522BZQ · Traditional | 09/11/1998SE |
| K981969 | Ultima Body Position SensorLEL · Traditional | 08/20/1998SE |
Questions and answers
When was MEDIPALM-20 cleared by the FDA?
MEDIPALM-20 (K031202) received a 510(k) decision of Substantially Equivalent on May 1, 2003, 15 days after the submission was received.
What is the product code of K031202?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.