Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COBE PPD 1.3L, #18-520-009

K-Number: K820694 · 1982-03-31

ApplicantCobe Laboratories, Inc.
Decision Date1982-03-31
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE PPD 1.3L, #18-520-009 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1982-03-31 under 510(k) number K820694. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE PPD 1.3L, #18-520-009?

COBE PPD 1.3L, #18-520-009 is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K820694.

When did COBE PPD 1.3L, #18-520-009 receive FDA 510(k) clearance?

COBE PPD 1.3L, #18-520-009 received FDA 510(k) clearance on 1982-03-31, under 510(k) number K820694.

Who is the listed applicant for COBE PPD 1.3L, #18-520-009?

The FDA 510(k) record lists Cobe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBE PPD 1.3L, #18-520-009?

The FDA product code for COBE PPD 1.3L, #18-520-009 is FJG.

Other records listing Cobe Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

View all 77 devices →

Related Devices (Code: FJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑