REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM— 510(k) K894299
Substantially EquivalentRepro-Med Systems, Inc.
FDA 510(k) clearance K894299 for REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM, Substantially Equivalent on 1989-09-22. Applicant: Repro-Med Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Repro-Med Systems, Inc.
- Product code
- Code BSY
- Device class
- Class 1
- Regulation
- 21 CFR 868.6810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middletown, NY, US
Recent devices under product code BSY
view allMore clearances from Repro-Med Systems, Inc.
view all- K102512 — RMS SUBCUTANEOUS NEEDLE SET
- K981506 — RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
- K933652 — FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
- K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM
- K844401 — REPRO-MED SYSTEMS INFUSION DEVICE
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
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.