Atlas FDA

TRANSONIC FLOWMETER

FDA 510(k) clearance K872048 · decided 1988-06-21

Clearance details

K-number
K872048
Device name
TRANSONIC FLOWMETER
Applicant
Transonic Systems, Inc.
Decision
Substantially Equivalent
Date received
1987-05-28
Decision date
1988-06-21
Days to decision
390 days
Clearance type
Traditional
Product code
DPW
Device class
2
Regulation number
870.2100
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ithaca, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-op recall (Z-2720-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra recall (Z-2721-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra recall (Z-2722-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra recall (Z-2723-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra- recall (Z-2724-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra- recall (Z-2725-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra recall (Z-2726-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra recall (Z-2727-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra recall (Z-2728-2015)Transonic Systems Inc2015-09-03
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra recall (Z-2729-2015)Transonic Systems Inc2015-09-03