510(k) K221782
- Device
- Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- Applicant
- Merit Medical Pte. , Ltd.
- 510(k) number
- K221782
- Product code
- DRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-17
- Date received
- 2022-06-21
- Regulation
- 870.2850
- Classification name
- Transducer, Blood-Pressure, Extravascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Pauline Liow
- Address
- 198 Yishun Ave. 7 Singapore SG 768926 768926
FDA Registration Numbers
- 2221819
- 9616675
- 1218950
- 1061124
- 3009156722
- 3016701404
- 3012536737
- 3009077524
- 3009001657
- 3008693658
- 8043983
- 1718873
- 3011237704
- 3005012805
- 8010042
- 2648727
- 2246552
- 1423537
- 1721676
- 3033589330
- 3006950086
- 3012307300
- 3006891665
- 3004832480
- 3017636737
- 1018233
- 3008403546
- 1423395
- 9612152
- 1422634
- 1625425
- 3012542015
- 1043214
- 3007048453
- 3002907620
- 1055236
- 3013319212
- 3016618143
- 9615817
- 3015173212
- 3008496528
- 3007603826
- 1713468
- 1526863
- 3012528160
- 2936999
- 1417592
- 1649914
- 1928237
- 1724474
- 3007836437
- 1319639
- 3007289408
- 3005595283
- 9610816
- 3017987980
- 3004519921
- 3003263092
- 3000126629
- 3005941719
- 3005580113
- 2032112
- 3016761372
- 3004605321
- 3013596024
- 9616088
- 3031233007
- 3004111573
- 3013500228
- 3013783488
- 2015691
- 8043969
- 9610849
- 1054241
- 2648045
- 3010421104
- 3009106351
- 8020616
- 3014541700
- 3015225571
- 3006082230
- 9616567
- 3007307487
- 9617594
- 3015309643
- 3032916632
- 1721504
- 3018094310
- 9681377
- 3015910259
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K123095 | MEDLINE BLOOD PRESSURE TRANSDUCER | Medline Industries, Inc. | 2013-05-08 |
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| K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | Mirador Biomedical, Inc. | 2011-12-14 |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | 2011-04-07 |
| K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | Mirador Biomedical, Inc. | 2011-01-20 |
| K101189 | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | Reavillmed | 2010-12-22 |
| K101518 | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | 2010-10-13 |