510(k) K960754
- Device
- SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
- Applicant
- MECTA CORP.
- 510(k) number
- K960754
- Product code
- GXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-18
- Date received
- 1996-02-23
- Regulation
- 882.5940
- Classification name
- Device, Electroconvulsive Therapy
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBIN H NICOL
- Address
- 7015 SW Mc Ewan Rd. Lake Oswego OR US 97035 97035
FDA Registration Numbers#
- 3023869663
- 1420295
Source Documents#
Legacy Summary#
summary
FDA Review#
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