Atlas FDA

MINGOGRAF EEG10

FDA 510(k) clearance K802296 · decided 1980-10-03

Clearance details

K-number
K802296
Device name
MINGOGRAF EEG10
Applicant
Siemens Corp.
Decision
Substantially Equivalent
Date received
1980-09-19
Decision date
1980-10-03
Days to decision
14 days
Clearance type
Traditional
Product code
GWQ
Device class
2
Regulation number
882.1400
Medical specialty
Neurology
Advisory committee
Neurology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (K261604)Neuroelectrics Barcelona S.L.U.2026-06-13
New Wave System (K260455)Zeto, Inc.2026-03-13
Flexset System (K233403)Zeto, Inc.2024-04-30
Neuronaute Plus (K231366)Bioserenity Sas2023-11-09
Q21 (K221959)Neurofield, Inc.2023-08-31
SPARK Scan (K231457)Spark Neuro, Inc.2023-08-18
Cumulus Functional Neurophysiology Platform (K221963)Cumulus Neuroscience Limited2023-04-27
Okti (K230073)Compumedics Limited2023-02-09
Neuronaute with IceCap 2 & IceCap 2 Small (K223644)Bioserenity2023-01-12
iSyncWave (K220056)iMediSync, Inc.2022-08-10
Seer Home (K212788)Seer Medical Pty, Ltd.2022-06-16
WAVi SCAN EEG System and Accessories (K213900)Wavi Co.2022-05-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (P110041/S017)Siemens Corp.2025-10-17
Atellica IM Hepatitis B surface Antigen II (HBsII) (P110041/S016)Siemens Corp.2025-10-17
ADVIA Centaur HBsAgII (HBsII) (P110041/S014)Siemens Corp.2025-06-04
ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay (P110041/S015)Siemens Corp.2025-03-04
Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con (P110041/S013)Siemens Corp.2022-03-29
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf) (P110041/S012)Siemens Corp.2021-04-27
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica (P110041/S011)Siemens Corp.2021-03-11
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010)Siemens Corp.2020-08-25