← Product Code [BYO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYO) · K924541

# EPIDURAL MINIPACK (K924541)

_Concord/Portex · BYO · Jul 9, 1993 · Anesthesiology · SESK_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYO/K924541

## Device Facts

- **Applicant:** Concord/Portex
- **Product Code:** [BYO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYO.md)
- **Decision Date:** Jul 9, 1993
- **Decision:** SESK
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5220
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYO/K924541](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYO/K924541)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com