Atlas FDA

Z VIEW METER MODEL 300

FDA 510(k) clearance K830823 · decided 1983-05-18

Clearance details

K-number
K830823
Device name
Z VIEW METER MODEL 300
Applicant
Lintronics Industries, Inc.
Decision
Substantially Equivalent
Date received
1983-03-15
Decision date
1983-05-18
Days to decision
64 days
Clearance type
Traditional
Product code
KRC
Device class
2
Regulation number
870.2370
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, MI, 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.

RecordFirmDate
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713)Sontra Medical, Inc.2004-01-28
BIOMA 3500 (K872370)E.B.S., Inc.1987-12-07
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (K874155)Circadian, Inc.1987-11-23
SKIN PREP ANALYZER (K874327)Marquette Electronics, Inc.1987-11-23
IMPEDANCE/8200 MONITOR-MODEL 8300 (K840358)Aequitron Medical, Inc.1984-10-30
CONDUCTANCE METER (K833619)Circadian, Inc.1984-01-27
PREP-CHECK (K830876)General Devices1983-05-18
GERARD MEDICAL ELECTRODE TESTER (K813358)Gerard Medical Enterprises, Inc.1981-12-29
ELECTRODE TESTER (K780501)Mg Medical Electronics1978-05-19
TS-100 TEST SYSTEM (K771014)Delta Medical Industries1977-06-14

Recalls involving this device

No recalls on record reference this clearance.