510(k) K770665
- Device
- VALVE, PRESSURE, DEMAND
- Applicant
- Mcgaw Respiratory Therapy
- 510(k) number
- K770665
- Product code
- CBD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-15
- Date received
- 1977-04-08
- Regulation
- 880.6740
- Classification name
- Bottle, Collection, Breathing System (Calibrated)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1526863
- 3009420598
- 3009197857
- 3012307300
- 3007360714
- 9613418
- 3012971441
Source Documents#
510(k) summary PDF not indicated by FDA