OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)— 510(k) K003704
Substantially EquivalentOptovent AB
FDA 510(k) clearance K003704 for OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE), Substantially Equivalent on 2001-02-05. Applicant: Optovent AB. Device class: 2.
Clearance details
- Applicant
- Optovent AB
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lee, NJ, US
Recent devices under product code BZQ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.