← Product Code [CCN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN) · K802037

# VITAMIN B12 FOLATE RADIOASSAY (K802037)

_Corning Medical & Scientific · CCN · Nov 21, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94monitoring-devices/CCN/K802037

## Device Facts

- **Applicant:** Corning Medical & Scientific
- **Product Code:** [CCN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN.md)
- **Decision Date:** Nov 21, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2300
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94monitoring-devices/CCN/K802037](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94monitoring-devices/CCN/K802037)

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