FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVILBISS PD1000
K Number: K020329
·
Decision Jun 19, 2002
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
10
Review Days
139
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Basic Information
- Device Name
- DEVILBISS PD1000
- K Number
- K020329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunrise Medical Hhg, Inc.
- Date Received
- January 31, 2002
- Decision Date
- June 19, 2002
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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Other Clearances by Sunrise Medical Hhg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083249 | QUICKIE RHYTHM | Dec 23, 2008 | Substantially Equivalent |
| K012437 | DEVILBISS SLEEP RECORDER MODEL # RM60 | Jul 16, 2002 | Substantially Equivalent |
| K020900 | DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM | Jun 3, 2002 | Substantially Equivalent |
| K011229 | DEVILBISS 9000 SERIES CPAP, MODEL 9001 | Jul 11, 2001 | Substantially Equivalent |
| K003626 | DEVILBISS HUMIDIFIER | May 4, 2001 | Substantially Equivalent |
| K993492 | DEVILBISS NEBULIZER MODEL 800 | Apr 21, 2000 | Substantially Equivalent |
| K991722 | DEVILBISS 5 LITER OXYGEN CONCENTRATOR | Nov 3, 1999 | Substantially Equivalent |
| K982304 | DEVILBISS SUCTION UNIT | Sep 25, 1998 | Substantially Equivalent |
| K981602 | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR | Jul 17, 1998 | Substantially Equivalent |