MagView BIOMAGNETOMETER SYSTEM
FDA 510(k) clearance K152184 · decided 2016-04-08
Clearance details
- K-number
- K152184
- Device name
- MagView BIOMAGNETOMETER SYSTEM
- Applicant
- Tristan Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-05
- Decision date
- 2016-04-08
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- OLY
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Orion LifeSpan MEG (K191785) | Compumedics Limited | 2020-02-14 |
| BABYMEG BIOMAGNETOMETER SYSTEM (K133419) | Tristan Technologies, Inc. | 2014-07-21 |
| MAGNES 2500 WH BIOMAGNETOMETER (K962317) | Biomagnetic Technologies, Inc. | 1997-05-07 |
| NEUROMAG-122 (K962764) | Philips Medical Systems (Cleveland), Inc. | 1996-10-31 |
| BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER (K854466) | Biomagnetic Technologies, Inc. | 1986-02-04 |
Recalls involving this device
No recalls on record reference this clearance.