510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Advanced Instrumentations, Inc.

Miami, FL, US

ADVANCED INSTRUMENTATIONS, INC. appears in FDA device records in Miami, FL. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Advanced Instrumentations, Inc. between 2009 and 2017. The busiest year on record is 2011, with 8. The most recent is 2017, with 2.

Clearances by year, as a table
510(k) clearance decisions for Advanced Instrumentations, Inc., by decision year
YearClearances
20091
20118
20121
20132
20142
20172
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYOSubstantially Equivalent
K172055DUS-7000 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K141194FM-3000 FETAL MONITORHGMSubstantially Equivalent
K132077PATIENT MONITORMHXSubstantially Equivalent
K132059DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROMHXSubstantially Equivalent
K120075AM-6000 ANESTHESIA MACHINEBSZSubstantially Equivalent
K112317FM-9000 PLUS FETAL AND MATERNAL MONITORHGMSubstantially Equivalent
K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLERKNGSubstantially Equivalent
K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMIYOSubstantially Equivalent
K111934PD-100 SERIES ULTRASONIC POCKET DOPPLERKNGSubstantially Equivalent
K112187FM-1000 PLUS FETAL MONITORHGMSubstantially Equivalent
K112159CMS-1000FM CENTRAL MONITORING SYSTEMHGMSubstantially Equivalent
K111805ECG SERIES ELECTROCARDIOGRAPHDPSSubstantially Equivalent
K112135ECG-6 SERIES ELECTROCARDIOGRAPHDPSSubstantially Equivalent
K082887PM-1000F+PATIENT MONITORMWISubstantially Equivalent

Registered establishments

FDA registered establishments for Advanced Instrumentations, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10662703000957797ADVANCED INSTRUMENTATIONS, INC.6800 NW 77TH COURT, Miami, FL 33166 US2026and 35 more, listed in full below

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

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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Advanced Instrumentations, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

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