510(k) K812825
- Device
- FLO-COR I
- Applicant
- BIOTRINE CORP.
- 510(k) number
- K812825
- Product code
- JAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-26
- Date received
- 1981-10-08
- Regulation
- 868.2550
- Classification name
- Pneumotachometer
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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 |
| K853085 | PAX METER | Peace Medical, Inc. | 1985-09-03 |
| K833265 | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | 1983-11-28 |
| 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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