510(k) K191785
- Device
- Orion LifeSpan MEG
- Applicant
- Compumedics Limited
- 510(k) number
- K191785
- Product code
- OLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-14
- Date received
- 2019-07-03
- Regulation
- 882.1400
- Classification name
- Magnetoencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William Alam
- Address
- 30-40 Flockhart St. Abbotsford AU 3067 3067
FDA Registration Numbers#
- 9613619
- 3014137562
- 9680891
- 1650946
Source Documents#
Other 510(k) Records For Product Code OLY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2016-04-08 |
| K133419 | BABYMEG BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2014-07-21 |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | 1997-05-07 |
| K962764 | NEUROMAG-122 | Philips Medical Systems (Cleveland), Inc. | 1996-10-31 |
| K854466 | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | Biomagnetic Technologies, Inc. | 1986-02-04 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases