510(k) K760816
- Device
- Pneumotachography System
- Applicant
- AFTERCAL, INC.
- 510(k) number
- K760816
- Product code
- GWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-29
- Date received
- 1976-10-12
- Regulation
- 866.3740
- Classification name
- Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923555 | CODMAN GAAB NEUROENDOSCOPE | Codman & Shurtleff, Inc. | 1993-03-23 |