Chrysalis Intelligence · Product Codes · QZW

QZW · Unclassified

3 clearances · 2 unique sponsors

Device class
Regulation —
Total clearances
3
2024-02-06 → 2026-07-20
Last 12 months
1
Unique sponsors
2
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Samsung Electronics Co., Ltd. 2 1 2026-07-20
Apple, Inc. 1 0 2024-09-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94799 CPT Low Sleep study or sleep apnea risk assessment; OTC device billing context unclear
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-20 K261011 Samsung Electronics Co., Ltd. Sleep Apnea Feature (v2.0)
2024-09-13 K240929 Apple, Inc. Sleep Apnea Notification Feature (SANF)
2024-02-06 DEN230041 Samsung Electronics Co., Ltd. Sleep Apnea Feature