VITACOMM 100 ESOPHAGEAL STETHOSCOPE
FDA 510(k) clearance K842309 · decided 1984-06-22
Clearance details
- K-number
- K842309
- Device name
- VITACOMM 100 ESOPHAGEAL STETHOSCOPE
- Applicant
- Vitacomm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-12
- Decision date
- 1984-06-22
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- BZT
- Device class
- 2
- Regulation number
- 868.1920
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.