Mmi/Gaeltec Series 8T Diff. Press. Trans

FDA 510(k) K801880 · Medical Measurements, Inc.

Substantially Equivalent

510(k) numberK801880

Submission

Device name
Mmi/Gaeltec Series 8T Diff. Press. Trans
Applicant
Medical Measurements, Inc.
Mchenry, IL, US
Received
August 7, 1980
Decision date
August 14, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYR – Transducer, Gas Pressure, Differential
Device class
Class I (low risk)
Regulation
21 CFR 868.2875
Specialty
Anesthesiology

Other 510(k)s with product code BYR

510(k)DeviceApplicantDecision
K896718Bicore Variflex(R) Flow TransducerBYR · Traditional Bicore Monitoring Systems02/22/1990SE
K790334Drager OrmBYR · Traditional Draeger Medical, Inc.03/07/1979SE

More from Draeger Medical, Inc.

510(k)DeviceDecision
K921062Gaeltec MPR SeriesFFX · Traditional 07/30/1992SE
K902097Model TR Rectal Suction Biopsy TubeFCK · Traditional 07/27/1990SE
K863479Modified Ict/B Intracranial Press. Trans. EpiduralGWM · Traditional 10/14/1986SE
K801757Mmi/Gaeltec Catheter Tip Press. TransduFES · Traditional 08/27/1980SE
K801756Mmi/Gaeltec Catheter Tip TransducDXO · Traditional 08/20/1980SE
K801758Mmi/Gaeltec Catheter IntrauterineKXO · Traditional 08/14/1980SE
K801755Mmi/Gaeltec Catheter Tip PressureGWM · Traditional 08/13/1980SE

Questions and answers

When was Mmi/Gaeltec Series 8T Diff. Press. Trans cleared by the FDA?

Mmi/Gaeltec Series 8T Diff. Press. Trans (K801880) received a 510(k) decision of Substantially Equivalent on August 14, 1980, 7 days after the submission was received.

What is the product code of K801880?

The FDA product code is BYR – Transducer, Gas Pressure, Differential, a Class I (low risk) device regulated under 21 CFR 868.2875.