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

Milwaukee, WI, US

Instrumentarium Corp. appears in FDA device records in Milwaukee, WI. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Instrumentarium Corp. between 1983 and 2002. The busiest year on record is 1988, with 4. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for Instrumentarium Corp., by decision year
YearClearances
19831
19851
19861
19884
19912
19932
19951
19962
19971
19981
19991
20002
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K022630MODIFICATION TO FOCUSEHDSubstantially Equivalent
K001729FOCUSEHDSubstantially Equivalent
K001439ORTHOCEPH OC100 DMUHSubstantially Equivalent
K992385ORTHOPANTOMOGRAPH OP100DMUHSubstantially Equivalent
K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQIZHSubstantially Equivalent
K962638TONOCAP, TC-200 AND ACCESSORY CATHETERSCCKSubstantially Equivalent
K961441TONOMETERED SLAINE BLOOD GAS CONTROLJJSSubstantially Equivalent
K955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORFFTSubstantially Equivalent
K934478ALPHA STEREOIZHSubstantially Equivalent
K923433AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULECBQSubstantially Equivalent
K930338ORTHOCEPH OC100EHDSubstantially Equivalent
K912893ORTHOPANTOMOGRAPH 100EHDSubstantially Equivalent
K904355CARDIOCAP II TM CH-RESP MONITORSDPSSubstantially Equivalent
K883621INSTRUMENTARIUM ULF MR IMAGING SYSTEMLNHSubstantially Equivalent
K883649INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110HLNHSubstantially Equivalent
K883650INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110LNHSubstantially Equivalent
K883622INSTRUMENTARIUM ULF MR IMAGING SYSTEMLNHSubstantially Equivalent
K853953CARDIOCAP MONITORDRTSubstantially Equivalent
K853396MULTICAP MULTIGAS CAPNOMETER PB252CCKSubstantially Equivalent
K833739CD-102 CARBON DIOXIDE ANALYZER/RECORCCJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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