Various Cameo Med Amniocentesis Trays, Disposable

Q: What is the product code of K922960?

The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.

FDA 510(k) K922960 · Cameo, Inc.

Unknown

510(k) numberK922960

Submission

Device name: Various Cameo Med Amniocentesis Trays, Disposable
Applicant: Cameo, Inc.
Toledo, OH, US
Received: June 18, 1992
Decision date: November 5, 1992
Decision: Unknown (SEKD)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: HIO – Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class: Class I (low risk)
Regulation: 21 CFR 884.1550
Specialty: Obstetrics/Gynecology

Other 510(k)s with product code HIO

510(k)	Device	Applicant	Decision
K960203	G.E. Sterile Amniocentesis TrayHIO · Traditional	GE Medical Systems	03/14/1996SE
K955679	RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional	Contour Fabricators of Florida, Inc.	03/12/1996SE
K914419	Amniotest(Tm)HIO · Traditional	Pro-Lab, Inc.	09/01/1993SE
K921738	Sono-Vu Us(Tm), ModificationHIO · Traditional	E-Z-Em, Inc.	04/27/1992SE
K915863	Mega Amniocentesis KitHIO · Traditional	Mega Medical, Inc.	03/30/1992SEKD
K904583	Sono-Vu Us(Tm)HIO · Traditional	E-Z-Em, Inc.	06/24/1991SE
K901643	Isoflo(Tm) Amniocentesis TrayHIO · Traditional	Healthdyne Cardiovascular, Inc.	07/25/1990SE
K900021	Percu-Set(Tm)HIO · Traditional	E-Z-Em, Inc.	03/29/1990SE
K896031	Amniotic Fluid Sampler (Amniocentesis Tray)HIO · Traditional	Concord/Portex	01/12/1990SE
K894031	Pharmaseal Genetic Amniocentesis TrayHIO · Traditional	Baxter Healthcare Corp	08/04/1989SESD

More from Baxter Healthcare Corp

510(k)	Device	Decision
K922962	Various Cameo Med Basic Biopsy Trays, DisposableKKX · Traditional	03/23/1993SEKD
K922961	Various Cameo Med Percutaneous Skin Prep Trays,KKX · Traditional	03/23/1993SEKD

Questions and answers

When was Various Cameo Med Amniocentesis Trays, Disposable cleared by the FDA?

Various Cameo Med Amniocentesis Trays, Disposable (K922960) received a 510(k) decision of Unknown on November 5, 1992, 140 days after the submission was received.

What is the product code of K922960?

The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.