FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VAPOTHERM MODEL#2000I, 200H
K Number: K042245
·
Decision Aug 30, 2004
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
13
Review Days
11
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Basic Information
- Device Name
- VAPOTHERM MODEL#2000I, 200H
- K Number
- K042245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vapotherm, Inc.
- Date Received
- August 19, 2004
- Decision Date
- August 30, 2004
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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| K111640 | PRECISION FLOW(R) - HELIOX | Oct 7, 2011 | Substantially Equivalent |
| K103316 | FLOWREST | Feb 8, 2011 | Substantially Equivalent |
| K072845 | PRECISION FLOW | Jul 17, 2008 | Substantially Equivalent |
| K070056 | VAPOTHERM MODEL# 2000I AND 2000H | Apr 13, 2007 | Substantially Equivalent |