510(k) K974697
- Device
- REUSABLE FINGER SENSOR 3444
- Applicant
- BCI INTL., INC.
- 510(k) number
- K974697
- Product code
- DQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-11
- Date received
- 1997-12-16
- Regulation
- 870.2310
- Classification name
- Cardiograph, Apex (vibrocardiograph)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD J ALEXANDER
- Address
- W238 N1650 Rockwood Dr. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3021343210
- 3012307300
Source Documents#
Legacy Summary#
summary
FDA Review#
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