510(k) K853085
- Device
- PAX METER
- Applicant
- PEACE MEDICAL, INC.
- 510(k) number
- K853085
- Product code
- JAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-03
- Date received
- 1985-07-23
- Regulation
- 868.2550
- Classification name
- Pneumotachometer
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN FEGAN
- Address
- 9 Great Meadow Ln. East Hanover NJ US 07936 07936
FDA Registration Numbers#
- 2183022
- 2938401
- 3012187635
- 3027437074
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990962 | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | 2000-01-07 |
| K921178 | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Medical Associated Services, Inc. | 1992-08-26 |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Spirometrics, Inc. | 1989-01-19 |
| K833265 | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | 1983-11-28 |
| K812825 | FLO-COR I | Biotrine Corp. | 1981-10-26 |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Research Development Corp. | 1979-11-16 |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Research Development Corp. | 1977-01-14 |
Legacy Summary#
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FDA Review#
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