CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK— 510(k) K993619
Substantially EquivalentSims Portex, Inc.
FDA 510(k) clearance K993619 for CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK, Substantially Equivalent on 2000-04-28. Applicant: Sims Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Portex, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code BSP
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view all- K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
- K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
- K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K001318 — CPAP SYSTEM, MODEL 102001
- K994275 — SIMS PORTEX ANESTHESIA CATHETER
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.