← FDA Medical Device Classifications
Pulse Oximeter For Over-The-Counter Use
OLK · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2700
Classification
- FDA Product Code
OLK- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.2700
- Review panel
- AN
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown