Pax Meter
FDA 510(k) K853085 · Peace Medical, Inc.
510(k) numberK853085
Submission
- Device name
- Pax Meter
- Applicant
- Peace Medical, Inc.
East Hanover, NJ, US - Received
- July 23, 1985
- Decision date
- September 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JAX – Pneumotachometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2550
- Specialty
- Anesthesiology
Other 510(k)s with product code JAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990962 | Flosense, Model 29-8010JAX · Traditional | Sdi Diagnostics, Inc. | 01/07/2000SE |
| K921178 | Pti-A, Pti-P, Pti-N Disposable PneumotachsJAX · Traditional | Medical Associated Services, Inc. | 08/26/1992SE |
| K884464 | Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional | Spirometrics, Inc. | 01/19/1989SE |
| K833265 | Respiratory Flow ModuleJAX · Traditional | Thoratec Laboratories Corp. | 11/28/1983SE |
| K812825 | Flo-Cor IJAX · Traditional | Biotrine Corp. | 10/26/1981SE |
| K791730 | Ring-Orifice, Turbulent Flow PneumotJAX · Traditional | Research Development Corp. | 11/16/1979SE |
| K770061 | Vo Respiratory PneumotachographJAX · Traditional | Research Development Corp. | 01/14/1977SE |
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Questions and answers
When was Pax Meter cleared by the FDA?
Pax Meter (K853085) received a 510(k) decision of Substantially Equivalent on September 3, 1985, 42 days after the submission was received.
What is the product code of K853085?
The FDA product code is JAX – Pneumotachometer, a Class II (moderate risk) device regulated under 21 CFR 868.2550.