← Product Code [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG) · K963035 # MICRO SPIROMETER (K963035) _Micro Direct, Inc. · BZG · Nov 1, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K963035 ## Device Facts - **Applicant:** Micro Direct, Inc. - **Product Code:** [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG.md) - **Decision Date:** Nov 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1840 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC. ## Device Story Hand-held portable electronic spirometer; measures FEV1 and FVC during patient exhalation. Uses flow-sensing turbine transducer; LCD display for output. Operated by clinicians in home or hospital settings. Device provides lung function measurements to assist clinical evaluation. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Hand-held electronic spirometer; flow-sensing turbine transducer; LCD display. Flow range 0-12 lps BTPS; volume range 0-9.99 liters. Accuracy +/- 3%. Utilizes paper mouthpiece; transducer requires cleaning after use. ## Regulatory Identification A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. ## Predicate Devices - Spirometrics Model 2600 Micro Spirometer ([K901057](/device/K901057.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} K963035 Micro Direct NOV - 1 1996 # Non-Confidential Summary of Safety and Effectiveness August 1, 1996 page 1 of 2 Micro Direct, Inc. 840 Pownal Rd. Auburn, ME 04210 Tel - (207) 786-7808 Fax - (207) 786-7280 Official contact: David R. Staszak, President Proprietary or Trade Name: Micro Spirometer Common/Usual Name: Diagnostic Spirometer Classification Name: 73 BZG - Diagnostic Spirometer Intended device: Diagnostic spirometer Predicate devices: Spirometrics Model 2600 Micro Spirometer - K901057 Device description: A hand-held portable electronic spirometer measuring FEV1 and FVC. ## Indicated use: The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC. ## Targeted population: Patients requiring lung function evaluations. ## Environment of use: Places where a qualified clinician desires to take these lung measurements - FEV1 and FVC. ## Comparison to predicate devices: | Attribute | Intended device | Spirometrics Model 2600 | | --- | --- | --- | | Use | | | | Intended as a spirometer | Yes | Yes | | Intended to measure lung function FEV1 and FVC | Yes | Yes | page 3 of 29 Micro Direct, Inc. • 840 Pownal Road • P. O. Box 239 • Auburn, ME 04212-0239 {1} Non-Confidential Summary of Safety and Effectiveness August 1, 1996 page 2 of 2 Comparison to predicate devices: (continued) | Attribute | Intended device | Spirometrics Model 2600 | | --- | --- | --- | | Use (continued) | | | | Indicated for measuring patients lung function | Yes | Yes | | Indicated for use by a clinician in environments such as the home or hospital | Yes | Yes | | Manufactured by Micro Medical | Yes | Yes | | Exact same unit as supplied to and marketed by Spirometrics and approved under K901057 | Yes | -- | | Design | | | | Transducer - flow sensing turbine | Yes | Yes | | No output | Yes | Yes | | Flow range Ips BTPS 0-12 | Yes | Yes | | Volume range liters 0-9.99 | Yes | Yes | | Measures - FVC - FEV1 | Yes | Yes | | Accuracy + / - 3 | Yes | Yes | | Display LCD | Yes | Yes | | Transducer cleaned after use | Yes | Yes | | Utilizes paper mouthpiece | Yes | Yes | | Materials | | | | Same materials as K901057 | Yes | Yes | | Performance Testing | | | | None applicable | Yes | Yes | ## Differences There is no difference between the intended device and the listed predicate device. page 4 of 29 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K963035](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K963035) **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