510(k) K771510
- Device
- SERVO-PAK MOLEL 0030
- Applicant
- Isothermal Systems, Inc.
- 510(k) number
- K771510
- Product code
- BXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-16
- Date received
- 1977-08-05
- Regulation
- 868.1975
- Classification name
- Analyzer, Gas, Water Vapor, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014680755
- 2028411
- 3013846070
- 3017676696
- 2080783
- 3016852448
- 3013501110
- 9611252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760246 | ENDOTRACHEAL T CONNECTOR | Sherwood Medical Industries | 1976-08-04 |