Time Watch

FDA 510(k) K772119 · Akzona, Inc.

Substantially Equivalent

510(k) numberK772119

Submission

Device name
Time Watch
Applicant
Akzona, Inc.
Mchenry, IL, US
Received
November 2, 1977
Decision date
November 14, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPK – Tubing, Fluid Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…FPK · Traditional Hospira, Inc.12/11/2006SE
K052431Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2…FPK · Traditional Medtronic Minimed11/29/2005SE
K041178Empower Transfer Set, (Cat. No. 7725)FPK · Traditional E-Z-Em, Inc.07/16/2004SE
K031808Medrad Swabbable Valve Transfer SetFPK · Special Medrad, Inc.07/11/2003SE
K022431Medrad Transfer SetFPK · Traditional Medrad, Inc.09/05/2002SE
K965208Polyfin Extension Set, Models 126 and 128FPK · Traditional Medtronic Minimed02/26/1997SE
K953864Silclear Tubing (Modification)FPK · Traditional Degania Silicone , Ltd.11/06/1995SE
K950508Sysmex SF-3000FPK · Traditional Sysmex Corp.11/03/1995SE

More from Sysmex Corp.

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Questions and answers

When was Time Watch cleared by the FDA?

Time Watch (K772119) received a 510(k) decision of Substantially Equivalent on November 14, 1977, 12 days after the submission was received.

What is the product code of K772119?

The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.