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

Medicomp, Inc.

Melbourne, FL, US

MEDICOMP, INC. appears in FDA device records in Melbourne, FL. FDA records list 23 510(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
23
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Medicomp, Inc. between 1983 and 2018. The busiest year on record is 1986, with 4. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medicomp, Inc., by decision year
YearClearances
19831
19842
19852
19864
19872
19883
19901
19941
19951
19981
20051
20092
20161
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173170Epicardia AnywhereDSISubstantially Equivalent
K161916TelePatch Cardiac MonitorDRGSubstantially Equivalent
K091696SAVI WIRELESS, MODEL PM500DRGSubstantially Equivalent
K090834EPICARDIA 5000DSISubstantially Equivalent
K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410MLOSubstantially Equivalent
K981119CARDIOPAL MODEL NUMBER PM20DXHSubstantially Equivalent
K952846EPICARDIADQKSubstantially Equivalent
K943915HEAT AND MOISTURE EXCHANGER FILTER (HME)BYDSubstantially Equivalent
K900207EPICARDIA 4000DSTSubstantially Equivalent
K883103EPICARDIA PC/FCDSISubstantially Equivalent
K881770EPICARDIA LE/FDDQKSubstantially Equivalent
K880434MEDICOMP STRAIGHT SWIVEL ADAPTORBZASubstantially Equivalent
K872837EPICARIDA, LEDSISubstantially Equivalent
K864896MEDICOMP INHALANT MASK ELBOWBZASubstantially Equivalent
K863643EPICARDIA, PC/FDDSISubstantially Equivalent
K861280MEDICOMP CPAP NASAL CANNULABZDSubstantially Equivalent
K852632GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUBCAISubstantially Equivalent
K852866HYDRO-BAC FILTERCAISubstantially Equivalent
K851666MEDI-COMP NEONATAL OXYGEN HOODBYLSubstantially Equivalent
K851070RESP-BAC BACTERIA FILTERCAHSubstantially Equivalent
K843513EPICARDIA, PCDSISubstantially Equivalent
K834034MODEM ACCESSORY FOR EPI CARDIA SYSDXHSubstantially Equivalent
K830013EPI CARDIA SYS. - AMBULATORY MONITORDSISubstantially Equivalent

Registered establishments

FDA registered establishments for Medicomp, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10336011033601MEDICOMP, INC.600 Atlantis Rd, Melbourne, FL 32904 US2026

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 Medicomp, 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