Medicomp Inc

FDA Filings

This page includes the latest FDA filings for Medicomp Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1033601
• FEI Number: 1033601
• Name: MEDICOMP, INC.
• Owner & Operator: Medicomp INC
• Contact Address: 600 Atlantis Rd ; Melbourne FL 32904 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 600 Atlantis Rd ; Melbourne, FL 32904 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00862887000388 MEDICOMP, INC.	TelePatch Cardiac Monitor	2023-10-03
GUDID 00862887000302 MEDICOMP, INC.	Epicardia 5000	2023-10-03
GUDID 00862887000371 MEDICOMP, INC.	TelePatch Cardiac Monitor	2019-11-08
GUDID 00862887000364 MEDICOMP, INC.	Decipher Holter Monitor	2019-11-08
GUDID 00862887000357 MEDICOMP, INC.	Cardiac Monitor	2019-11-08
GUDID 00862887000340 MEDICOMP, INC.	CardioPAL SAVI	2019-11-08
PMN K173170 | DSI MEDICOMP, INC. [Medicomp INC]	Epicardia Anywhere	2018-01-22
PMN K173170 Medicomp, Inc.	Epicardia Anywhere	2018-01-10
PMN K161916 | MLO MEDICOMP, INC. [Medicomp INC]	Universal Pendant	2017-08-15
PMN K161916 | MLO MEDICOMP, INC. [Medicomp INC]	TelePatch Cardiac Monitor	2017-08-15
PMN K161916 | DRG MEDICOMP, INC. [Medicomp INC]	Universal Pendant	2017-08-15
PMN K161916 | DRG MEDICOMP, INC. [Medicomp INC]	TelePatch Cardiac Monitor	2017-08-15
PMN K161916 MEDICOMP, INC.	TelePatch Cardiac Monitor	2016-12-21
PMN K981119 | DXH MEDICOMP, INC. [Medicomp INC]	CardioPal SAVI	2011-12-01
PMN K952846 | DQK MEDICOMP, INC. [Medicomp INC]	Epicardia	2011-12-01
PMN K091696 | DRG MEDICOMP, INC. [Medicomp INC]	SAVI Wireless/SAVI Air/Cardiac Monitor/Duet/TelePATCH	2011-12-01
PMN K090834 | DSI MEDICOMP, INC. [Medicomp INC]	Epicardia 5000/Beacon	2011-12-01
PMN K043454 | MLO MEDICOMP, INC. [Medicomp INC]	CardioPal AI	2011-12-01
PMN K091696 MEDICOMP, INC.	SAVI WIRELESS, MODEL PM500	2009-10-26
PMN K090834 MEDICOMP, INC.	EPICARDIA 5000	2009-05-15
PMN K043454 MEDICOMP, INC.	CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410	2005-03-24
PMN K981119 MEDICOMP, INC.	CARDIOPAL MODEL NUMBER PM20	1998-10-14
PMN K952846 MEDICOMP, INC.	EPICARDIA	1995-09-18
PMN K943915 MEDICOMP, INC.	HEAT AND MOISTURE EXCHANGER FILTER (HME)	1994-10-14
PMN K900207 MEDICOMP, INC.	EPICARDIA 4000	1990-07-31
PMN K883103 MEDICOMP, INC.	EPICARDIA PC/FC	1988-09-22
PMN K881770 MEDICOMP, INC.	EPICARDIA LE/FD	1988-05-31
PMN K880434 MEDICOMP, INC.	MEDICOMP STRAIGHT SWIVEL ADAPTOR	1988-03-31
PMN K872837 MEDICOMP, INC.	EPICARIDA, LE	1987-11-04
PMN K864896 MEDICOMP, INC.	MEDICOMP INHALANT MASK ELBOW	1987-02-20
PMN K863643 MEDICOMP, INC.	EPICARDIA, PC/FD	1986-12-05
PMN K861280 MEDICOMP, INC.	MEDICOMP CPAP NASAL CANNULA	1986-05-09
PMN K852632 MEDICOMP, INC.	GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB	1986-01-03
PMN K852866 MEDICOMP, INC.	HYDRO-BAC FILTER	1986-01-01
PMN K851666 MEDICOMP, INC.	MEDI-COMP NEONATAL OXYGEN HOOD	1985-08-06
PMN K851070 MEDICOMP, INC.	RESP-BAC BACTERIA FILTER	1985-06-14
PMN K843513 MEDICOMP, INC.	EPICARDIA, PC	1984-10-22
PMN K834034 MEDICOMP, INC.	MODEM ACCESSORY FOR EPI CARDIA SYS	1984-05-09
PMN K830013 MEDICOMP, INC.	EPI CARDIA SYS. - AMBULATORY MONITOR	1983-02-28

Related Finance Registrations

NCAGE Code	0K8H0	MEDICOMP INC
NCAGE Code	0V6B2	MEDICOMP, INC.
CAGE Code	0K8H0	MEDICOMP INC
CAGE Code	0V6B2	MEDICOMP, INC.
S.A.M. Registration	0V6B2 [57729253]	MEDICOMP, INC.
SEC	0000738332	MEDICOMP INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020071744838	Hong Kong,Hong Kong -> Long Beach, California	CABLE ASSEMBLY THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	5 CTN
202007154389	Hong Kong,Hong Kong -> Miami, Florida	DUAL CHANNEL PATCH HS CODE:90181910	180 CTN
2020061312206	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	POWER ADAPTER 5V2A DUAL CHANNEL PATCH	85 CTN
201911047282	Shekou,China (Mainland) -> Miami, Florida	CABLE ASSEMBLY THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	7 CTN
201903112367	Hong Kong,Hong Kong -> Miami, Florida	CRADLE, PENDANT SLIDE, PATCH STANDARD CTN = 900PCS CTN X 55CTN REMAINDER CTN = 500PCS CTN X 1CTN HS CODE:392690 . . .	56 CTN
201902233820	Hong Kong,Hong Kong -> Miami, Florida	CABLE ASSEMBLY HS CODE:85444211 THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	7 CTN
201808242901	Hong Kong,Hong Kong -> Miami, Florida	CABLE ASSEMBLY HS CODE:85444211 THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	34 CTN
2018081013885	Hong Kong,Hong Kong -> Miami, Florida	CABLE ASSEMBLY HS CODE:85444211 THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	34 CTN