510(k) K152184
- Device
- MagView BIOMAGNETOMETER SYSTEM
- Applicant
- TRISTAN TECHNOLOGIES, INC
- 510(k) number
- K152184
- Product code
- OLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-08
- Date received
- 2015-08-05
- 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
- KEVIN PRATT
- Address
- 6191 Cornerstone Ct., Suite 107 San Diego CA US 92121 92121
FDA Registration Numbers#
- 9680891
- 1650946
- 9613619
- 3014137562
Source Documents#
Other 510(k) Records For Product Code OLY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191785 | Orion LifeSpan MEG | Compumedics Limited | 2020-02-14 |
| 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#
summary
FDA Review#
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