FDA.reportPublic FDA data

spECTrum

Primary DI
00861539000110
Brand
spECTrum
Company
MECTA CORPORATION
Model
5000DM
Device description
100 Joule ECT Device with 1 Parameter Setting Control and Patient Monitoring
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXCDevice, Electroconvulsive Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXCDevice, Electroconvulsive TherapyNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965070000SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.1997-03-06QGH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861539000110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861539000110008615390001108615390001100861539000110

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(503) 612-6780info@mectacorp.com

Regulatory Flags#

DUNS number
037079324
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861539000103spECTrum5000DQ2014-09-24
00861539000127spECTrum4000DQ2014-09-24
00861539000134spECTrum4000DM2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007003Thymatron IVSOMATICS, LLCGXC2018-08-23
00607915110758Surgical Ratchet ClipAPPLIED MEDICAL RESOURCES CORPORATIONGXC2016-09-24
10607915110755Surgical Ratchet ClipAPPLIED MEDICAL RESOURCES CORPORATIONGXC2016-09-24
00861539000103spECTrumMECTA CORPORATIONGXC2014-09-24
00861539000127spECTrumMECTA CORPORATIONGXC2014-09-24
00861539000134spECTrumMECTA CORPORATIONGXC2014-09-24