secwatch.observer — SEC 8-K summary
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Issuer:     Owlet, Inc. (OWLT)
CIK:        0001816708
Form:       8-K
Filed at:   2022-12-22T23:59:59+00:00
Accession:  0001628280-22-032483
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Owlet's de novo submission for Health Notifications SaMD for heart rate and oxygen
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- FDA accepted for substantive review Owlet's de novo classification request for over-the-counter SaMD 'Health Notifications'.
- Health Notifications would provide live heart rate and oxygen saturation displays and notifications via Dream Sock.
- This is Owlet's second FDA submission in 2022; first was a 510(k) for a prescription monitor in October.
- CEO Kurt Workman stated FDA authorization could uniquely position Owlet to help caregivers with live health data.
- De novo pathway is for low-to-moderate risk devices with no legally marketed predicate.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/0001628280-22-032483-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/owlt-20221222.htm
  HTML page:      https://secwatch.observer/filing/0001628280-22-032483

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer