Decision Date2000-08-23
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PALM PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sorenson Medical, Inc.. It received FDA 510(k) clearance on 2000-08-23 under 510(k) number K002434. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PALM PUMP?
PALM PUMP is a medical device that received FDA 510(k) clearance on 2000-08-23. The listed applicant is Sorenson Medical, Inc.. The 510(k) number is K002434.
When did PALM PUMP receive FDA 510(k) clearance?
PALM PUMP received FDA 510(k) clearance on 2000-08-23, under 510(k) number K002434.
Who is the listed applicant for PALM PUMP?
The FDA 510(k) record lists Sorenson Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PALM PUMP?
The FDA product code for PALM PUMP is MEA.
Other records listing Sorenson Medical, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K052221AMBIT PUSH & PLAY AMBULATORY INFUSION PUMPK033325AMBIT CONTINUOUS AMBULATORY INFUSION PUMPK033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMPK001287EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLK99136330 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
Related Devices (Code: MEA)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.