Atlas FDA

FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

FDA 510(k) clearance K071387 · decided 2007-06-15

Clearance details

K-number
K071387
Device name
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
Applicant
Fresenius Medical Care North America
Decision
Substantially Equivalent
Date received
2007-05-18
Decision date
2007-06-15
Days to decision
28 days
Clearance type
Special
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hem recall (Z-2373-2015)Fresenius Medical Care Holdings, Inc.2015-08-12
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid) recall (Z-1827-2015)Fresenius Medical Care Holdings, Inc.2015-06-22
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concent recall (Z-2686-2014)Fresenius Medical Care Holdings, Inc.2014-09-23
NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis recall (Z-1739-2014)Fresenius Medical Care Holdings, Inc.2014-06-09
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The co recall (Z-1639-2014)Fresenius Medical Care Holdings, Inc.2014-05-22
Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis recall (Z-2551-2011)Fresenius Medical Care Holdings, Inc.2011-06-10