# Regulations.gov document: Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use — retained record

> Retained regulations record from regulations-gov.

Canonical: https://highsignal.app/data/records/a4e3b76da6098b18

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source: [regulations](https://highsignal.app/data/regulations) (regulations-gov)  published 2026-10-09 04:00 ingested 2026-10-10 02:39

[original source ↗](https://www.regulations.gov/document/FDA-2026-N-10993-0001)

## retained text



```
Query: data center
Agency: FDA
Type: Rule
Docket: FDA-2026-N-10993
```



document fetched 2026-10-13 02:43 · canonical https://regulations.gov/document/FDA-2026-N-10993-0001