EQUINOX RELIEVE— 510(k) K113687
Substantially EquivalentO-Two Medical Technologies, Inc.
FDA 510(k) clearance K113687 for EQUINOX RELIEVE, Substantially Equivalent on 2012-04-30. Applicant: O-Two Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- O-Two Medical Technologies, Inc.
- Product code
- Code BZR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5330
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code BZR
view allMore clearances from O-Two Medical Technologies, Inc.
view allRecalls naming K113687
K-number listed on FDA's recall record- Z-2887-2018 — CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
- Z-2885-2018 — O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113687.
Data sourced from openFDA. This site is unofficial and independent of the FDA.