510(k) K841858
- Device
- Spiroloop
- Applicant
- DATAMED, INC.
- 510(k) number
- K841858
- Product code
- BSE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-11
- Date received
- 1984-05-04
- Regulation
- 868.1640
- Classification name
- Analyzer, Gas, Helium, Gaseous-Phase
- 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#
- 3013500228
- 3033959233
- 3013596024
- 9615102
- 3008483389
Source Documents#
510(k) summary PDF not indicated by FDA