TRANSTAR PRESSURE TRANSDUCER— 510(k) K942377
Substantially EquivalentMedex, Inc.
FDA 510(k) clearance K942377 for TRANSTAR PRESSURE TRANSDUCER, Substantially Equivalent on 1994-08-16. Applicant: Medex, Inc.. Device class: 2.
Clearance details
- Applicant
- Medex, Inc.
- Product code
- Code DPT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilliard, OH, US
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More clearances from Medex, Inc.
view allRecalls naming K942377
K-number listed on FDA's recall record- Z-0184-2025 — medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
- Z-0185-2025 — medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
- Z-0186-2025 — medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K942377.
Data sourced from openFDA. This site is unofficial and independent of the FDA.