VENTEX-IA
FDA 510(k) clearance K864641 · decided 1987-01-28
Clearance details
- K-number
- K864641
- Device name
- VENTEX-IA
- Applicant
- Ventech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-26
- Decision date
- 1987-01-28
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- IKN
- Device class
- 2
- Regulation number
- 890.1375
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.