The Spira Elektro 2
FDA 510(k) K871151 · Warren E. Collins, Inc.
510(k) numberK871151
Submission
- Device name
- The Spira Elektro 2
- Applicant
- Warren E. Collins, Inc.
Braintree, MA, US - Received
- March 23, 1987
- Decision date
- May 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5640
- Specialty
- Anesthesiology
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| K852102 | Collin Body Plethysmograph Plus SystemCCM · Traditional | 07/31/1985SE |
| K831780 | Metabolic Exercise Testing SystemBZL · Traditional | 09/12/1983SE |
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| K831777 | Collins DSBZC · Traditional | 08/31/1983SE |
| K831779 | Collins Eagle IIBZC · Traditional | 08/26/1983SE |
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Questions and answers
When was The Spira Elektro 2 cleared by the FDA?
The Spira Elektro 2 (K871151) received a 510(k) decision of Substantially Equivalent on May 15, 1987, 53 days after the submission was received.
What is the product code of K871151?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.