Ec 5R Plethysmograph
FDA 510(k) K932812 · D. E. Hokanson, Inc.
510(k) numberK932812
Submission
- Device name
- Ec 5R Plethysmograph
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- June 9, 1993
- Decision date
- January 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JEH – Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Specialty
- Anesthesiology
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| K953642 | AP-18JEH · Traditional | Jeneric/Pentron, Inc. | 12/12/1995SE |
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| K925040 | TelepulseJEH · Traditional | Biometrix , Ltd. | 08/23/1993SE |
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| K973426 | Ans 2000 ECG Monitor and Respiration PacerDPS · Traditional | 08/12/1998SE |
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| K932852 | Non Invasive Vascular ProgramJOB · Traditional | 02/04/1994SE |
| K932851 | Disposable Penile Blood Pressure CuffsDXQ · Traditional | 11/15/1993SE |
| K905367 | E-20 Rapid Cuff InflatorDXN · Traditional | 03/06/1991SE |
| K901592 | Model MD-5 DopplerDXK · Traditional | 10/22/1990SE |
Questions and answers
When was Ec 5R Plethysmograph cleared by the FDA?
Ec 5R Plethysmograph (K932812) received a 510(k) decision of Substantially Equivalent on January 13, 1994, 218 days after the submission was received.
What is the product code of K932812?
The FDA product code is JEH – Plethysmograph, Volume, a Class II (moderate risk) device regulated under 21 CFR 868.1760.