510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Mission Systems Davenport Inc.

Davenport, IA, US

Mission Systems Davenport Inc. appears in FDA device records in Davenport, IA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Mission Systems Davenport Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Carleton Life Support Systems, Inc.510(k), recall

510(k) clearance history

FDA records hold 3 510(k) clearances for Mission Systems Davenport Inc. between 2005 and 2008. The busiest year on record is 2005, with 1. The most recent is 2008, with 1.

Clearances by year, as a table
510(k) clearance decisions for Mission Systems Davenport Inc., by decision year
YearClearances
20051
20071
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K082829AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)OLFSubstantially Equivalent
K071904DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)CAWSubstantially Equivalent
K051887PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)CAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Mission Systems Davenport Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30028405313002840531Mission Systems Davenport Inc.2734 Hickory Grove Rd, DAVENPORT, IA 52804 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2009-2009Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain