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

Walker, MI, US

Infrasonics Corp. appears in FDA device records in Walker, MI. 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 Infrasonics Corp. between 1984 and 1995. The busiest year on record is 1992, with 6. The most recent is 1995, with 2.

Clearances by year, as a table
510(k) clearance decisions for Infrasonics Corp., by decision year
YearClearances
19843
19851
19871
19882
19891
19902
19911
19926
19931
19952
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K943106ADULT VENTILATORCBKSubstantially Equivalent - Subject to Tracking Reg.
K952878OXY/STAR LOW FLOW BLENDERBZRSubstantially Equivalent
K934753STAR BREATHING CIRCUITSBZOSubstantially Equivalent
K922654VENTILATOR ADULT STAR MODIFICATIONCBKSubstantially Equivalent
K923704INFANT STAR SERIES 500CBKSubstantially Equivalent
K922477MODEL 105 VENTILATOR, MODIFICATIONCBKSubstantially Equivalent
K920954AIR STARBTISubstantially Equivalent
K911804INFRASONICS VENTILATOR ADULT STAR, MODIFICATIONCBKSubstantially Equivalent
K913972STAR SYNC, MODIFICATIONCBKSubstantially Equivalent
K905272ADULT STAR, MODIFICATIONCBKSubstantially Equivalent
K896825TRANSCUTANEOUS ELECTRONIC NERVE STIMULATORGZJSubstantially Equivalent
K895963MODIFIED STAR CALCBZCSubstantially Equivalent
K884521STAR SYNCCBKSubstantially Equivalent
K875027STAR CALCBZCSubstantially Equivalent
K872466ADULT STARCBKSubstantially Equivalent
K873395HOYER SOLVETCAFSubstantially Equivalent
K853487PATIENT BREATHING CIRCUITBZDSubstantially Equivalent
K842580ACCESSORY FOR ADULT VOL. VENTILATORCAHSubstantially Equivalent
K843036PATIENT BREATHING CIRCUITBZOSubstantially Equivalent
K840865INFANT STAR VENTILATORCBKSubstantially 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