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FDA 510(k)

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

K-Number: K222608 · 2022-12-16

ApplicantTuttnauer , Ltd.
Decision Date2022-12-16
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is a medical device manufactured by Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-12-16 under approval number K222608. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Tuttnauer , Ltd.. The 510(k) number is K222608.

When was Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS approved by the FDA?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS received FDA 510(k) clearance on 2022-12-16, under approval number K222608.

What company makes Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is manufactured by Tuttnauer , Ltd..

What is the FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

The FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is FLE.

Other Devices by Tuttnauer , Ltd.

K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves K221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 K213080T-Edge 10, T-Edge 11

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

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.

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