← Product Code [BXX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX) · K801258

# NEEDLE COUNTER-SURE COUNT/10 COUNT (K801258)

_Kleen Test Products · BXX · Jun 4, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801258

## Device Facts

- **Applicant:** Kleen Test Products
- **Product Code:** [BXX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX.md)
- **Decision Date:** Jun 4, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2620
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801258](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXX/K801258)

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