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

C.G.H. Medical, Inc.

Lakewood, CO, US

C.G.H. Medical, Inc. appears in FDA device records in Lakewood, CO. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for C.G.H. Medical, Inc. between 1991 and 1995. The busiest year on record is 1994, with 5. The most recent is 1995, with 2.

Clearances by year, as a table
510(k) clearance decisions for C.G.H. Medical, Inc., by decision year
YearClearances
19911
19923
19945
19952
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K941708COBE CENTRYSYSTEM CS500 DIALYZERFJISubstantially Equivalent
K933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERKDISubstantially Equivalent
K925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONKOCSubstantially Equivalent
K920757FILTRAL HEMODIALYZERSKDISubstantially Equivalent
K931720LUNDIA ALPHA 700 HEMODIALYZERKDISubstantially Equivalent
K924437HEMOSPAL KIT B22 / MULTIFLOW 60 KITKDISubstantially Equivalent
K940601GAMBRO BICART 720GKPOSubstantially Equivalent
K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSCANSubstantially Equivalent
K914271GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)CANSubstantially Equivalent
K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSFJGSubstantially Equivalent
K911603HEMOSPAL KIT B22KDISubstantially 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.

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 C.G.H. Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for C.G.H. Medical, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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