Vital Pep
FDA 510(k) K984468 · Vital Signs, Inc.
510(k) numberK984468
Submission
- Device name
- Vital Pep
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- December 16, 1998
- Decision date
- June 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
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| K001553 | Breas PV 100 CPAP SystemBZD · Traditional | 08/03/2000SE |
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Questions and answers
When was Vital Pep cleared by the FDA?
Vital Pep (K984468) received a 510(k) decision of Substantially Equivalent on June 1, 1999, 167 days after the submission was received.
What is the product code of K984468?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.