510(k) K133419
- Device
- BABYMEG BIOMAGNETOMETER SYSTEM
- Applicant
- TRISTAN TECHNOLOGIES INC
- 510(k) number
- K133419
- Product code
- OLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-21
- Date received
- 2013-11-07
- 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
- EUGENE HIRSCHKOFF
- Address
- 3365 Calle Margarita Encinitas CA US 92024 92024
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 |
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2016-04-08 |
| 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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