FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
K Number: K854466
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
- K Number
- K854466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Biomagnetic Technologies, Inc.
- Date Received
- November 6, 1985
- Decision Date
- February 4, 1986
- Product Code
- OLY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLY | Magnetoencephalograph | FDA class 2 | Neurology |
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Other Clearances by Biomagnetic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993708 | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | Dec 3, 1999 | Substantially Equivalent |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | May 7, 1997 | Substantially Equivalent |
| K941553 | MAGNES II BIOMAGNETOMETER | May 16, 1996 | Substantially Equivalent |
| K921821 | IBT MODEL SVI | Nov 2, 1992 | Substantially Equivalent |
| K913604 | SOMATOSENSORY STIMULUS SYSTEM | Dec 9, 1991 | Substantially Equivalent |
| K901215 | 700 SERIES BIOMAGNETOMETER | Jun 25, 1990 | Substantially Equivalent |
| K790031 | GENERATOR, BIOTEC 876 PULSE | Jan 2, 1979 | Unknown |