Regulatory filing

DEN180044 (us_fda)

FDA De Novo DEN180044 for Apple Watch ECG (2018). Also K240929 for sleep apnea (2024), K250507 for hypertension (2025). SpO2 NOT cleared (wellness-only).

fda de novo · active · decided 2018-09-11

Track DEN180044 (us_fda)

Machine-readable surfaces

Markdown mirror: /regulatory-filings/apple-watch-fda-de-novo-den180044.md
JSON-LD: embedded in this page’s head
REST API: /v1/filings/2c30913a-09cf-4ce3-9382-05901dbbfeda
Revision history: /regulatory-filings/apple-watch-fda-de-novo-den180044/history
Data documentation: /data
Query this programmatically: Deploy MCP

Key facts

Jurisdiction: us_fda
Filing type: fda de novo
Status: active
Filing number: DEN180044
Filing date: 2018-01-01
Decision date: 2018-09-11
Verification posture: verified
Cap-flag notes: SpO2 NOT cleared, wellness-only. Honest absence.

Applicant

Apple

Covered models (1)

Apple Watch

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN180044

Deploy Watch

Track DEN180044 (us_fda).

We notify you when the filing status changes or related filings, incidents, or litigations surface.

Identity

2c30913a-09cf-4ce3-9382-05901dbbfeda