Embla System LLC
Tonawanda, NY, US
Embla System Llc appears in FDA device records in Tonawanda, NY. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 1
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1532-2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772 | Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain